This document provides information about Doruk Sistem Engineering, Technology, Consultancy and Chemical Management Systems Inc. Co., which was established in 2005 to guide companies in Turkey and globally on chemical industry regulations. It offers services related to regulatory compliance with Turkey, EU, and global standards, including product registration support, risk assessments, and development of quality control systems and compliance programs. Doruk Sistem consultants assist clients across various industries, such as chemicals, cosmetics, pesticides, and more. The document outlines Doruk Sistem's expertise, capabilities, and history and provides examples of its regulatory consulting and advisory services.
Doruk Sistem Engineering, Technology, Consultancy and Chemical Management Systems Inc. Co. is a Turkish consulting company established in 2005 to help chemical, cosmetic, and agricultural clients comply with Turkish, EU, and global regulations. The company provides regulatory consulting services related to product registration, testing, safety assessments, and developing compliance programs. Doruk Sistem has a team of regulatory experts and scientists with experience in Turkey, the EU, and international regulatory systems. The company aims to be a trusted partner for its clients in navigating regulatory requirements.
Doruk Sistem is a Turkish consulting company established in 2005 to help chemical and industrial clients comply with Turkish, EU, and global regulations. It provides a wide range of regulatory consulting services including TURKREACH compliance, dossier preparation, SDS authoring, and certification services. Doruk Sistem has a team of experienced regulatory consultants and scientists and works with major international clients to navigate complex regulatory requirements.
Doruk Chemical Management Systems Consultancy Co. Ltd. has been established in 2005 to guide and lead to the chemical manufacturers, exporters and importers for the compliance of Europian Union, Global and Local legislations and regulations.
Doruk Sistem is currently continuing to the professional consultancy services like certification for the chemical industry, intallations of quality systems, R&D Support, product development, establishing the chemical safety management systems, REACH and SEVESO II compliance, material safety data sheet authoring, label validation, technical system design for safety and health applications in chemical plants,licensing of the chemical manufacturing premises for the local legislations
Doruk Sistem is a leading provider of regulatory consulting and testing services with a strong focus on chemical compliance.
With a strong presence in EU and Turkey , Doruk Sistem has provided cost-effective regulatory support and testing services to lots of companies while doing businesses in both the EU and Turkey .
TNO Triskelion BSL-3 lab tests anti-viral drugs in newly developed H7N9 influenza model
Human infections with a new avian influenza A (H7N9) virus were first reported in China in 2013, with the loss of 46 lives. In order to meet the growing needs to test new drugs against H7N9, TNO Triskelion has recently developed an H7N9 mouse model. This H7N9 model is suitable for testing new anti-virals such as vaccines, monoclonal antibodies and small molecules in our BSL-3 lab, in conformity with Good Laboratory Practice. TNO Triskelion has proven to be a successful partner in the development of new anti-viral and anti-bacterial vaccines for many years. Understanding the pressures on time lines, we support companies and institutes during the preclinical and clinical stages of drug development.
Certification agencies ensure that food service equipment meets safety and sanitation standards through testing and certification. In the US, the main agencies are NSF International, Underwriters Laboratory (UL), and CSA International. NSF International certifies that equipment complies with food safety and sanitation requirements, while UL tests products for safety and CSA certifies compliance with Canadian standards. Other international standards organizations that certify compliance with their requirements include ETL SEMKO, which certifies for both the US and internationally, and the CE marking for equipment sold in Europe. Third-party testing laboratories like the Food Service Technology Center conduct testing to evaluate equipment performance claims.
Certification agencies ensure that food service equipment meets minimum safety and sanitation requirements through independent third-party testing and certification. Major certification agencies include NSF International, Underwriters Laboratories (UL), CSA International, and Conformité Européenne (CE), with each focusing on specific geographic regions and standards. Certification provides assurance to customers, manufacturers, and health authorities that equipment is properly designed, constructed, and will perform safely as intended.
The document discusses product compliance and environmental regulations that companies must address, such as RoHS, REACH, and WEEE. It introduces Oracle's Agile Product Governance & Compliance solution which helps companies manage compliance across their products and supply chains by enabling them to collect supplier declarations, analyze products for compliance, and track regulatory documentation. The solution decreases compliance costs while reducing business risk and improving operational governance.
The Parenteral Drug Association Italy Chapter is hosting a one-day conference on September 10, 2015 to discuss highlights from recent PDA conferences on parenteral packaging and aseptic manufacturing. The forum will provide updates on regulations and technologies related to sterile products production, including container closure integrity and environmental monitoring. Speakers from pharmaceutical companies and vendors will present case studies and the latest technology solutions to help companies improve quality standards and compliance.
Doruk Sistem Engineering, Technology, Consultancy and Chemical Management Systems Inc. Co. is a Turkish consulting company established in 2005 to help chemical, cosmetic, and agricultural clients comply with Turkish, EU, and global regulations. The company provides regulatory consulting services related to product registration, testing, safety assessments, and developing compliance programs. Doruk Sistem has a team of regulatory experts and scientists with experience in Turkey, the EU, and international regulatory systems. The company aims to be a trusted partner for its clients in navigating regulatory requirements.
Doruk Sistem is a Turkish consulting company established in 2005 to help chemical and industrial clients comply with Turkish, EU, and global regulations. It provides a wide range of regulatory consulting services including TURKREACH compliance, dossier preparation, SDS authoring, and certification services. Doruk Sistem has a team of experienced regulatory consultants and scientists and works with major international clients to navigate complex regulatory requirements.
Doruk Chemical Management Systems Consultancy Co. Ltd. has been established in 2005 to guide and lead to the chemical manufacturers, exporters and importers for the compliance of Europian Union, Global and Local legislations and regulations.
Doruk Sistem is currently continuing to the professional consultancy services like certification for the chemical industry, intallations of quality systems, R&D Support, product development, establishing the chemical safety management systems, REACH and SEVESO II compliance, material safety data sheet authoring, label validation, technical system design for safety and health applications in chemical plants,licensing of the chemical manufacturing premises for the local legislations
Doruk Sistem is a leading provider of regulatory consulting and testing services with a strong focus on chemical compliance.
With a strong presence in EU and Turkey , Doruk Sistem has provided cost-effective regulatory support and testing services to lots of companies while doing businesses in both the EU and Turkey .
TNO Triskelion BSL-3 lab tests anti-viral drugs in newly developed H7N9 influenza model
Human infections with a new avian influenza A (H7N9) virus were first reported in China in 2013, with the loss of 46 lives. In order to meet the growing needs to test new drugs against H7N9, TNO Triskelion has recently developed an H7N9 mouse model. This H7N9 model is suitable for testing new anti-virals such as vaccines, monoclonal antibodies and small molecules in our BSL-3 lab, in conformity with Good Laboratory Practice. TNO Triskelion has proven to be a successful partner in the development of new anti-viral and anti-bacterial vaccines for many years. Understanding the pressures on time lines, we support companies and institutes during the preclinical and clinical stages of drug development.
Certification agencies ensure that food service equipment meets safety and sanitation standards through testing and certification. In the US, the main agencies are NSF International, Underwriters Laboratory (UL), and CSA International. NSF International certifies that equipment complies with food safety and sanitation requirements, while UL tests products for safety and CSA certifies compliance with Canadian standards. Other international standards organizations that certify compliance with their requirements include ETL SEMKO, which certifies for both the US and internationally, and the CE marking for equipment sold in Europe. Third-party testing laboratories like the Food Service Technology Center conduct testing to evaluate equipment performance claims.
Certification agencies ensure that food service equipment meets minimum safety and sanitation requirements through independent third-party testing and certification. Major certification agencies include NSF International, Underwriters Laboratories (UL), CSA International, and Conformité Européenne (CE), with each focusing on specific geographic regions and standards. Certification provides assurance to customers, manufacturers, and health authorities that equipment is properly designed, constructed, and will perform safely as intended.
The document discusses product compliance and environmental regulations that companies must address, such as RoHS, REACH, and WEEE. It introduces Oracle's Agile Product Governance & Compliance solution which helps companies manage compliance across their products and supply chains by enabling them to collect supplier declarations, analyze products for compliance, and track regulatory documentation. The solution decreases compliance costs while reducing business risk and improving operational governance.
The Parenteral Drug Association Italy Chapter is hosting a one-day conference on September 10, 2015 to discuss highlights from recent PDA conferences on parenteral packaging and aseptic manufacturing. The forum will provide updates on regulations and technologies related to sterile products production, including container closure integrity and environmental monitoring. Speakers from pharmaceutical companies and vendors will present case studies and the latest technology solutions to help companies improve quality standards and compliance.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects.
View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda
Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
This document summarizes the key changes and requirements of the revised OSHA Hazard Communication Standard to align it with the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Notable changes include standardized label elements like pictograms and a 16-section Safety Data Sheet format. Employers must train workers on the new label formats and SDS by December 2013 and update alternative workplace labeling and hazard programs by June 2016.
This document provides information on the "Discovering the Route to Regulatory Compliance" conference taking place on September 23-24, 2015 in Barcelona, Spain. The conference will address topics related to regulatory compliance with REACH, including preparing for the 2018 registration deadline, managing substances of very high concern (SVHCs) and applications for authorization, substance and dossier evaluation, safety data sheets, and more. It lists keynote speakers from the European Chemicals Agency and industry organizations discussing these topics.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
Medwisdom is a pharmaceutical consulting company that offers a wide range of services including regulatory affairs, intellectual property, analytical development, formulation development, technology transfer, training, auditing, and pharmacovigilance. Their services include dossier preparation, patent drafting, method development and validation, new product development, process improvements, technology transfer, GMP training, quality and regulatory audits, and pharmacovigilance services like safety database management and reporting.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
PCA is a solution designed to ensure products meet import regulations in target overseas markets. It assists exporters to comply with regulations by providing reassurance through product testing, inspection of labels and manuals, and certification. Governments have partnered with SGS to implement PCA programs nationwide in countries like Algeria, Kenya, and Nigeria. The PCA program checks for product safety, health impacts, and environmental effects through tests and reviews of certificates. It provides flexibility on compliance depending on the product. Relevant standards are set by national authorities according to international, regional, or other country's standards. SGS is an authorized provider to verify conformity according to a country's PCA program.
Can I Use My International SDS in Canada?Dell Tech
This session will provide a quick overview of the requirements for the Canadian Safety Data Sheet (SDS). Current Canadian SDSs must comply with the Hazardous Products Regulations (HPR) and in particular, GHS Version 5 statements.
If you manufacture or sell product(s) in other countries, you must have an SDS that is compliant for the country you are looking to sell to. Sending your US SDS and simply translating into Canadian French does not mean that your product SDS is compliant here - a fact that is often overlooked by many.
Treated articles refers to items treated with pesticide or preservative. Learn about the regulatory requirements for selling treated articles in Canada.
The presentation complemented a 60 minutes webinar on ISO IDMP provided by Cunesoft in May 2015. Benefits of a regulatory master data management system are being analyzed. The entire webinar was recorded. The latest information on IDMP can be accessed on our website: https://www.phlexglobal.com/idmp
ChemPharm is a consulting firm that provides services to the pharmaceutical, biotechnology, medical device, and cosmetics industries to help them achieve compliance with international quality standards. It has experts in areas like quality assurance, quality control, production, logistics, product development, and regulatory affairs. ChemPharm conducts activities like gap assessments, quality system implementations, audits, inspections preparations, and training. It aims to be a long-term partner to clients and help them go beyond just meeting requirements to gaining a competitive advantage.
The EI Group provides a wide range of environmental, health and safety compliance services to simplify regulatory requirements for businesses. Their services include program development, audits, inspections, training and consulting to help clients create or improve safety programs. EI offers specialized services in areas like industrial hygiene, environmental compliance, occupational health and safety training.
Alcumus ISOQAR India Pvt. Ltd. PresentationPalvi Shah
Alcumus is a market leader in compliance risk management and certification services, offering solutions such as management system certification, health and safety consultancy, and HR solutions. They have over 5000 customers, including 30% of FTSE 100 companies, and deliver audits against over 25 standards with a network of over 300 consultants worldwide. Alcumus seeks to build robust compliance strategies for clients through specialist expert advice and user-friendly technology.
Alcumus ISOQAR India Pvt. Ltd. PresentationPalvi Shah
Alcumus is a market leader in compliance risk management and certification services, offering solutions such as management system certification, health and safety consultancy, and HR solutions. They have over 5000 customers, including 30% of FTSE 100 companies, and deliver audits against over 25 standards with a network of over 300 consultants globally. Alcumus seeks to build robust compliance strategies for clients through specialist expert advice and user-friendly technology.
Alcumus ISOQAR India Pvt. Ltd. Corporate PresentationBhargav Upadhyay
This document provides an overview of Alcumus, a market leader in compliance risk management and certification services. It details Alcumus' various business units that provide solutions such as management system certification, health and safety consultancy, software solutions, and training. Alcumus has over 5000 customers, including 30% of FTSE 100 companies. It is a leading UK certification body and fastest growing. The document outlines Alcumus' range of certification, software, consulting, and training services across industries like construction, manufacturing, and healthcare.
ChemPharm is a consulting firm that provides expert services to support the pharmaceutical, biotechnology, medical device, traditional Chinese medicine, and cosmetic industries. It helps clients achieve compliance with international standards through services such as quality management system development and upgrades, validation, regulatory affairs support, and training. ChemPharm works with a variety of clients from multinational corporations to national companies and start-ups. Its goal is to be a trusted partner through high integrity, professionalism, and sharing of strategic information and vision.
Lead auditor training environmental management system irca approvedIntertek Moody
Intertek is an internationally accredited certification body that provides training and certification for various management systems including ISO 14001 for environmental management. The document announces a 5-day ISO 14001 lead auditor training course that will provide in-depth knowledge of environmental management system auditing requirements through lectures, case studies, and role plays. The course is approved by the International Register of Certificated Auditors. Participants will learn about environmental aspects and impacts, documentation, audit planning and performance, and continual improvement techniques. Upon satisfactory completion, participants will receive a certificate to help qualify them as certified auditors.
Lead auditor training environmental management system irca approvedIntertek Moody
Intertek is an internationally accredited certification body that provides training and certification for various management systems including ISO 14001 for environmental management. The document announces a 5-day ISO 14001 lead auditor training course that will provide in-depth knowledge of environmental management system auditing requirements through lectures, case studies, and role plays. The course is approved by the International Register of Certificated Auditors. Participants will learn about environmental aspects and impacts, documentation, audit procedures, and continual improvement techniques to meet the requirements for certification as an ISO 14001 lead auditor.
ADMIXTIO wants to be your new R&D partner. Our team has a long experience in the markets of personal care, food & beverages, cleaning and disinfection. We are specialized at product development, regulations and testing.
At ADMIXTIO’s laboratories we are able to carry out microbiological tests and development of formulations. We have an important network of contacts at universities and research centers, to perform scientific tests related to projects in the sectors mentioned above.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects.
View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda
Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
This document summarizes the key changes and requirements of the revised OSHA Hazard Communication Standard to align it with the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Notable changes include standardized label elements like pictograms and a 16-section Safety Data Sheet format. Employers must train workers on the new label formats and SDS by December 2013 and update alternative workplace labeling and hazard programs by June 2016.
This document provides information on the "Discovering the Route to Regulatory Compliance" conference taking place on September 23-24, 2015 in Barcelona, Spain. The conference will address topics related to regulatory compliance with REACH, including preparing for the 2018 registration deadline, managing substances of very high concern (SVHCs) and applications for authorization, substance and dossier evaluation, safety data sheets, and more. It lists keynote speakers from the European Chemicals Agency and industry organizations discussing these topics.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
Medwisdom is a pharmaceutical consulting company that offers a wide range of services including regulatory affairs, intellectual property, analytical development, formulation development, technology transfer, training, auditing, and pharmacovigilance. Their services include dossier preparation, patent drafting, method development and validation, new product development, process improvements, technology transfer, GMP training, quality and regulatory audits, and pharmacovigilance services like safety database management and reporting.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
PCA is a solution designed to ensure products meet import regulations in target overseas markets. It assists exporters to comply with regulations by providing reassurance through product testing, inspection of labels and manuals, and certification. Governments have partnered with SGS to implement PCA programs nationwide in countries like Algeria, Kenya, and Nigeria. The PCA program checks for product safety, health impacts, and environmental effects through tests and reviews of certificates. It provides flexibility on compliance depending on the product. Relevant standards are set by national authorities according to international, regional, or other country's standards. SGS is an authorized provider to verify conformity according to a country's PCA program.
Can I Use My International SDS in Canada?Dell Tech
This session will provide a quick overview of the requirements for the Canadian Safety Data Sheet (SDS). Current Canadian SDSs must comply with the Hazardous Products Regulations (HPR) and in particular, GHS Version 5 statements.
If you manufacture or sell product(s) in other countries, you must have an SDS that is compliant for the country you are looking to sell to. Sending your US SDS and simply translating into Canadian French does not mean that your product SDS is compliant here - a fact that is often overlooked by many.
Treated articles refers to items treated with pesticide or preservative. Learn about the regulatory requirements for selling treated articles in Canada.
The presentation complemented a 60 minutes webinar on ISO IDMP provided by Cunesoft in May 2015. Benefits of a regulatory master data management system are being analyzed. The entire webinar was recorded. The latest information on IDMP can be accessed on our website: https://www.phlexglobal.com/idmp
ChemPharm is a consulting firm that provides services to the pharmaceutical, biotechnology, medical device, and cosmetics industries to help them achieve compliance with international quality standards. It has experts in areas like quality assurance, quality control, production, logistics, product development, and regulatory affairs. ChemPharm conducts activities like gap assessments, quality system implementations, audits, inspections preparations, and training. It aims to be a long-term partner to clients and help them go beyond just meeting requirements to gaining a competitive advantage.
The EI Group provides a wide range of environmental, health and safety compliance services to simplify regulatory requirements for businesses. Their services include program development, audits, inspections, training and consulting to help clients create or improve safety programs. EI offers specialized services in areas like industrial hygiene, environmental compliance, occupational health and safety training.
Alcumus ISOQAR India Pvt. Ltd. PresentationPalvi Shah
Alcumus is a market leader in compliance risk management and certification services, offering solutions such as management system certification, health and safety consultancy, and HR solutions. They have over 5000 customers, including 30% of FTSE 100 companies, and deliver audits against over 25 standards with a network of over 300 consultants worldwide. Alcumus seeks to build robust compliance strategies for clients through specialist expert advice and user-friendly technology.
Alcumus ISOQAR India Pvt. Ltd. PresentationPalvi Shah
Alcumus is a market leader in compliance risk management and certification services, offering solutions such as management system certification, health and safety consultancy, and HR solutions. They have over 5000 customers, including 30% of FTSE 100 companies, and deliver audits against over 25 standards with a network of over 300 consultants globally. Alcumus seeks to build robust compliance strategies for clients through specialist expert advice and user-friendly technology.
Alcumus ISOQAR India Pvt. Ltd. Corporate PresentationBhargav Upadhyay
This document provides an overview of Alcumus, a market leader in compliance risk management and certification services. It details Alcumus' various business units that provide solutions such as management system certification, health and safety consultancy, software solutions, and training. Alcumus has over 5000 customers, including 30% of FTSE 100 companies. It is a leading UK certification body and fastest growing. The document outlines Alcumus' range of certification, software, consulting, and training services across industries like construction, manufacturing, and healthcare.
ChemPharm is a consulting firm that provides expert services to support the pharmaceutical, biotechnology, medical device, traditional Chinese medicine, and cosmetic industries. It helps clients achieve compliance with international standards through services such as quality management system development and upgrades, validation, regulatory affairs support, and training. ChemPharm works with a variety of clients from multinational corporations to national companies and start-ups. Its goal is to be a trusted partner through high integrity, professionalism, and sharing of strategic information and vision.
Lead auditor training environmental management system irca approvedIntertek Moody
Intertek is an internationally accredited certification body that provides training and certification for various management systems including ISO 14001 for environmental management. The document announces a 5-day ISO 14001 lead auditor training course that will provide in-depth knowledge of environmental management system auditing requirements through lectures, case studies, and role plays. The course is approved by the International Register of Certificated Auditors. Participants will learn about environmental aspects and impacts, documentation, audit planning and performance, and continual improvement techniques. Upon satisfactory completion, participants will receive a certificate to help qualify them as certified auditors.
Lead auditor training environmental management system irca approvedIntertek Moody
Intertek is an internationally accredited certification body that provides training and certification for various management systems including ISO 14001 for environmental management. The document announces a 5-day ISO 14001 lead auditor training course that will provide in-depth knowledge of environmental management system auditing requirements through lectures, case studies, and role plays. The course is approved by the International Register of Certificated Auditors. Participants will learn about environmental aspects and impacts, documentation, audit procedures, and continual improvement techniques to meet the requirements for certification as an ISO 14001 lead auditor.
ADMIXTIO wants to be your new R&D partner. Our team has a long experience in the markets of personal care, food & beverages, cleaning and disinfection. We are specialized at product development, regulations and testing.
At ADMIXTIO’s laboratories we are able to carry out microbiological tests and development of formulations. We have an important network of contacts at universities and research centers, to perform scientific tests related to projects in the sectors mentioned above.
This 6-month internship report summarizes services provided by TÜV SÜD South Asia Pvt. Ltd., a leading testing, inspection, and certification company. The report describes TÜV SÜD's history and global presence. It provides an overview of the wide range of testing, auditing, inspection, training, and certification services offered to ensure product and system quality and compliance across many industries. A major focus is food inspection services to check for quality and compliance throughout the production process.
Hughes Risk Management is a progressive consultancy that provides tailored risk management solutions internationally. It employs qualified professionals with experience in industries like oil/gas, renewables, chemicals, transportation and manufacturing. HRM delivers services like HSE management, technical safety studies, regulatory submissions, design support and more. It has a global client base and associations to offer comprehensive services.
Medwisdom services include Gap Analysis, Due Diligence, Crisis Avoidance, Formulation Development, Technology Transfer, Intellectual Property, Technical Dossier Preparation, Company Registration, Medical Devices, Training, Gxp Audit, Facilitate In Import/export
This document provides an overview of services offered by Medwisdom Lifesciences Private Limited, an Indian regulatory consulting firm. The company assists clients with regulatory submissions for pharmaceuticals, herbal products, nutraceuticals, cosmetics, and medical devices to international regulatory authorities. Services include dossier preparation, responding to regulatory queries, product lifecycle management, pre-cGMP audits, regulatory intelligence, documentation writing, and auditing. The company aims to help small and medium pharmaceutical firms comply with regulations through technical and regulatory support.
1 MB 20 DEC 2016 CV - GMP GDP QMS ISO 9001 13485 PV RAMichael Bonett
Michael Bonett is a senior quality regulatory manager and certified auditor with over 16 years of experience in quality assurance and regulatory compliance within the pharmaceutical and medical device industries. He has extensive expertise in risk management, auditing, process validation, and ensuring adherence to regulations. Bonett is currently looking to relocate within Europe and holds qualifications and experience in quality management, pharmacovigilance, and regulatory affairs.
The Operon Strategist provides regulatory, quality assurance, and marketing authorization services for medical devices, pharmaceuticals, research and development centers, contract research organizations, laboratories, and hospitals. It assists with facility setup, quality management systems, accreditations, certifications, and training. The company owns branches in India, Ireland, and China, and aims to deliver high-quality, timely, and cost-effective services with a commitment to confidentiality and compliance with international regulatory standards.
Oilfield Inspection Consultants LLP is an oilfield service company providing inspection services to the oil and gas industry in Kazakhstan and globally. The company has offices in Aktau and Aksai, Kazakhstan. It has a pool of qualified inspectors who perform inspections using calibrated equipment according to international standards. The company provides various inspection services including casing and tubing inspections, BHA inspections, drill pipe inspections, and lifting equipment inspections. It is committed to quality, health, safety, and environmental standards.
This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses Pharmalink's history, capabilities, experience, and case studies. Pharmalink was founded in 1998 and works with 18 of the top 20 healthcare companies. They have offices globally and can provide regulatory assistance across the entire product lifecycle from non-clinical development to post-approval tasks. Case studies demonstrate experience with large, global projects involving compliance, mergers and acquisitions, and product licenses.
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1. ‘Your Partner at Turkey’
www.doruksistem.com.tr
‘The heart of TURKREACH KKDIK’
‘when Quality is your Priority’
2. Doruksistem Engineering, Technology,
Consultancy and Chemical Management
Systems Inc. Co.
DORUKSISTEM Engineering Technology and Consultancy Co Inc. was established
in 2005 to guide and lead to the chemical industry, industrial chemicals -
cosmetics manufacturers – pesticide/agrochemicals/biocidal products registrants,
grower/commodity groups, trade associations exporters, importers and chemical
process industry to compliance with Turkish, EU and global regulations and in
dealing with issues that affect their ability to do business effectively.
DORUKSISTEM consultants have been involved in the preparation of vulnerability
analyses, including the evaluation of regulatory, quality control, and business
systems, and the development of standard operating procedures, global
regulatory models, and compliance manuals and programmers. With a strong
presence in Turkey, DORUKSISTEM has provided cost-effective regulatory support
and testing services to many valued companies while doing businesses in both
the EU and Turkey. DORUKSISTEM is the most experienced leader consultant
company in Turkey and your partner on the way of TURKREACH (KKDIK).
3. Our Expertise
Our regulatory expertise includes regulatory consultants
and scientists who have extensive experience dealing with
Turkey, EU, and global issues and regulations.
We assist chemical manufacturers, cosmetics
manufacturers, pesticide registrants, grower/commodity
groups, and trade associations in dealing with issues that
affect their ability to do business effectively.
Our regulatory consultants and scientists provide strategic
advice concerning regulatory compliance.
4. «Big Picture»
Doruk Sistem’s consultants work with clients to consider the “Big Picture” by
assessing and integrating the regulatory, technical, strategic, and business aspects
of each issue on local and global levels.
Using this integrated approach, our consultants advise clients on issues such as
product registration, due diligence, registrability assessments, product
development, product stewardship strategies, experimental use permits, and
reduced risk submissions.
Doruk Sistem consultants have been involved in the preparation of vulnerability
analyses, including the evaluation of regulatory, quality control, and safety
systems, and the development of standard operating procedures, global
regulatory models, and compliance manuals and programs.
5. OUR CAPABILITIES
• Doruk Sistem’s Center for Chemical Regulation and Industrial Safety
specializes in timely, high-quality, creative, and practical solutions to
problems that affect our clients' ability to conduct business local and
globally.
• Our experienced staff includes both technical and regulatory consultants
who are experienced in dealing with with pesticide and non-pesticide
products, including conventional chemicals, biochemicals, agrichemicals,
microbials, antimicrobials, consumer products, and products of
biotechnology.
• We draw upon expertise in a variety of backgrounds, including
epidemiology, biostatistics, toxicology, ecotoxicology, environmental
sciences, and risk modeling, to best meet our clients’ needs.
• Our international team and partners of regulatory and scientific experts
offers additional support for agrichemicals and biocides regulated under
Turkey, EU and US directives. Whatever your needs, Doruk Sistem can
augment your regulatory team and provide flexible, strategic consulting.
6. Our History
2005 - DORUKSISTEM founded in Istanbul, Turkey.
2006 - DORUKSISTEM launched leading edge solutions for authoring and managing production
quality and R&D management systems for the chemical process industry.
2007 - DORUKSISTEM completed more than 50 TSE/TSEK certification for the Turkish chemical
industry.
2008 - MSDSMARKET is established and published on www. msdsarket.com.tr
2010 - DORUKSISTEM Head Office opened. More than 4,500 CICL (Chemical Inventory Control
Legislation) notifications completed for several global companies.
2011 - DORUKSISTEM awarded ISO 9001 by Bureau Veritas.
2012 - Process safety department established.
2013 - Process safety business started.
2014 - More than 35,000 SDSs completed according to Turkish SDS legislation (DSD/DPD/CLP) in
total.
2015 - DORUKSISTEM R&D Technology branch opened at Tubitak Research Complex ın free zone
Martek Kocaeli Area.
2016 - DORUKSISTEM approved as an associated member of ORO, the Only Representatives
Organisation
2017– DORUKSISTEM moved all facilities to TUBITAK Marmara Technology Free Zone Area as an
approved R&D company.
8. Monitoring International regulatory changes
Turkish Chemical and related Regulations, Export and Import testing
and analysis, procedures follow-ups, Turkish Standards Institution’s
Certifications, etc.
SEVESO, IPPC, GHS, PIC, etc. regulations compliance
Product Safety Compliance
Biocidal Products, Plant Production Products, Veterinary Products,
Cleaning Chemicals etc., Regulations and import permissions &
licensing services
Following up of the industrial legislations and import documentation
and certification etc.
Following up & warning services on the industrial legislations,
General consultancy on Turkish and International chemical
regulationsn
Marketing and Authorization Applications for Regulatory Affairs
Monitoring & Following
Documentation and Licensing
Notification and Registration
Consulting and Advisory
Compilation
9. The assistance we can provide for TURKREACH Regulation KKDIK includes but
is not limited to:
–Regulatory strategy and advice
–Programme and project management
–Pre-SIEF application and management for TURKREACH
–SIEF and consortia management – SIEF Formation Facilitator services and
full SIEF/consortium management or participation
–Data evaluation and gap analysis – determination of availability of data held
by a company and in the public domain and evaluation of their suitability ,
review of data within the SIEF, literature searches and identification of data
gaps
–Use of Intelligent Testing Strategies (ITS) – identification of data gaps,
consideration of grouping and read across, exposure and technical data
waivers, expert statements and QSAR modelling
–Study placement and monitoring
–Dossier preparation and submission – complete dossier in KKS system for
TURKREACH including robust and end point study summaries, enquiry
dossiers, testing proposals, classification and labelling and toxicokinetics
assessment
–Chemical safety assessments/reports – identification of uses and exposure
routes, hazard assessment, DNEL/PNEC derivation, PBT/vPvB assessment,
exposure assessment and development of exposure scenarios, risk
characterisation and recommendations on risk management measures
–Evaluation and authorisation services – post submission, support,
negotiation with TR Chemical Help Desk of MoEU, applications for
authorisation and socio‐economic analysis
–Only Representative and Third Party Representative services
TURKREACH (KKDIK)
Consulting and Advisory
Registration
Technical Services
Trainings
10. Environmental Risk Management
Identifying and Understanding Environmental Risks and Liabilities is a must especially
for Chemical Companies. Understanding these makes it possible to safeguard against
and manage these risks and liabilities.
The Doruk Sistem Environmental Risk Management service encompass determining
prevailing current and estimating futures Environmental Risks and Liabilities and
recommending a strategy for managing these risks.
Energy Efficiency Services
Doruk Sistem provides solutions for developing organisation wide energy efficiency
programs to:
• Decrease the corporate carbon footprint,
• Conserve energy,
• Measuring energy efficiency performance.
Furthermore, Doruk Sistem supports in implementing actual energy efficiency
measures with proper tools for monitoring performances.
Environmental Risk Management
Green Chemicals Management
Carbon footprint
Eco friendly final products
Enviromental Regulatory Compliance
11. Responsible Person
Technical Dossier Preperation
Safety Assestment
Consultancy
Bespoke formulation
We offer the following services to our corporate clients:
• Safety Assessment / Toxicology Report
• Product Information File assessment and creation
• Fragrance Allergen declaration
• EU and TR Labelling and packaging compliance
• Consultancy in all areas of EU and TR cosmetic laws
• GMP Consultancy and Audit
• Bespoke Product Formulation and Manufacturing
• Responsible Person Services
• Notification Services
Current clients include both SME and major manufacturers and suppliers
from within and outside the EU.
12. Certification Consultancy
Risk Management
Auditing
Evaluation
Inspection
We offer the following consulting and asvisory services to our
corporate clients:
• Quality Management System (ISO 9001)
• Environmental Management System (ISO 14001)
• Occupational Health and Safety Management System (OHSAS
18001)
• Risk Management Profiling and Policy Development
• Quality Assurance
• Chemical Safety Management
• Auditing
• Inspection
• Advisory
13. Risk Assestment
Auditing
Evaluation
Regulatory Advice
We offer the following consulting and advisory services
to our corporate clients:
•Workplace Risk Assessments
•Corporate Health and Safety Audit
•Health and Safety Support Service – Navigator
•Task and Staff Risk Assessments
•Regulatory advice
•Industrial Hygiene
We can also liaise with enforcing authorities, bespoke
solutions for your business comprising:
• Initial health and safety consultant’s diagnostic visit
• Comprehensive documentation and handbooks
• Implementation and training
• Further visits to review compliance
• Regular support and advice
14. Safety Data Sheet
Extended SDS , Exposure Scenerio
SDS Software
CLP Compilation
Label Validation
MsdsMarket is leader in delivering high quality, chemical regulatory
compliance Safety Data Sheets (MSDS) authoring, compilation and technical
translations.
We are committed to providing our clients with first rate services, regardless
of the regulatory challenge.
MSDSMARKET Authoring/Writing Service assists companies in
Authoring/creating, auditing, writing and updating MSDS, SDS, extended
SDS, Exposure Scenerio, CLP Classification
Our Technical expert staff has created more than thousands of SDS sheets
for both internal purposes and as consultants to our customers.
www.msds.com.tr
Please visit our web page now.
15. Seminars
Webinars
Courses
Workshops
Inhouse trainings
SDS Expert Certification
Ministry Approved Trainings in TURKREACH
Some of our traing topics are as follows:
• EU and TR Chemical Regulatory Compliance
• TURKREACH KKDIK Regulation
• Chemical Safety Specialist Approved Training Center
• EU REACH Regulation
• Safety Data Sheet (Approved & Certified Expert Courses)
• CLP/GHS Classifications
• Cosmetics Regulations (SA and SE management)
• GMP and GLP
• Chemical Safety Assestment
• Biocidal Products Regulations
• Waste Management
• Work Place Health and Safety
• DG Goods Transportation and Classification
• Hazardous Chemicals Classification
• SEVESO - COMAH Regulation Compliance Topics
• Risk Analysis Methods in Proses Safety
• Risk Analysis Software Trainings, (HAZOP, BowTie,
Consequence Modelling, Risk Frequency Analysis etc)
• SDS Software trainings
• Chemical Risk Management
• More and more in Doruk Sistem Academy
16. Pharmaceuticals
Chemicals
Agrochemicals
Biocides
Medical Devices
Cosmetics
Food
REACH
SVHC,
ROHS,
WEEE
POHS and more
DIN EN ISO / IEC 17025
Technical Competence, Biocompatibility tests and
Microbiological tests for Medical Devices
GMP
Safety, Conformity with Specifications, Microbiological
tests and Bioassays in vitro / in vivo for pharmaceuticals
/ biologics
GLP
Traceability, Toxicology, Pharmacology in vitro / in vivo,
Pharmacocinetics, ADME, Analytics, Microbiological tests
and Bioassays in vitro / in vivo for pharmaceuticals /
biologics
FDA
Our Partner Laboratory was inspected by the US Food
and Drug Administration successfully in July 2006 and
2011.
17. We support our clients in protecting the health
and safety of man and the environment.
Our customers are industrial enterprises that
represent the chemical, pharmaceutical,
automotive, electronics, manufacturing and retail
industries, to name but a few.
Our solutions include software, process
expertise, implementation services, regulatory
content and managed services.
18. ADVANTAGES OF COLLABORATION
WITH DORUKSISTEM
Communication channels with Turkish Ministries and Municipalities.
Follow up of Turkish and EU regulations about chemical industry and
environment relations.
Follow up updated technologies about chemical compliance and
environmental services.
Networking with industry associations to forecast their needs.
Better understanding of global expertise, served in local philosophy.
Experienced, well organized, certified team.
19. Doruk Sistem works with
TSE & TURKAK certificated experts
to manage TURKREACH KKDIK process as CAS – KDU and to
author and compile legal Safety Data Sheets
26. ‘Your partner at Turkey’
Our «Only Representative» services;
TURKREACK KKDIK Full Compliance and Consultancy,Dossier
Preperation, Crossword translation from IUCLID To KKS, CSR,CSA
Prereparation with certified specialists, SIEF/CONSORTIA (including LR,
SFF, LoA,etc.) Management (e)SDS Authoring, Compilation &
Management, TURK CLP (SEA) registrations, Licensing for Biocidals,
Plant Protection Products, Cosmetics, Pesticides, etc., Chemical
Management System Solutions and all other related regulatory
compliance topics you needed.
info@doruksistem.com.tr
when Quality is your Priority