Doruksistem Presentation

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.

7. OUR SERVICES
«Chemical Management Systems»

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

20. Our Team

21. Doruk Sistem is an
ISO 9001:2015
awarded Company

22. Our Partners and Collaborations
Organisatons,Universities
Middle East Technical
University
And more …

23. SOME OF OUR INTERNATIONAL CLIENTs
And more …

24. www. turkreach.com.tr
Visit us now at
www.turkreach. com.tr

25. www.doruksistem.com.tr
Visit us now at
www.doruksistem.com.tr

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