Stabicon Life Sciences is a contract research organization located in Bangalore, India. It was established in 2010 and is approved by regulatory agencies in India, Canada, and the US. The company offers formulation development, analytical testing, stability studies, and other CRO services. It has a dedicated cGMP and cGLP compliant laboratory with experienced professionals and facilities for method development, validation, microbiology testing, and more. Stabicon aims to deliver high quality services to pharmaceutical clients at competitive costs while maintaining confidentiality and assisting throughout product development and registration.
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
From preclinical to commercial: The evolution of ADC manufacturing expertise ...MilliporeSigma
ADCs have evolved since the initial approval of MYLOTARG® in 2000, with respect to both conjugation, linker and toxin chemistries as well as processing. With the current availability of four commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain to make manufacturing efficient. With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.
MilliporeSigma has been involved with the development and manufacturing of ADCs since 2008. This webinar will discuss how chemistry and manufacturing have evolved over the past 10 years globally and how MilliporeSigma, as a CDMO has adapted to these changes to meet customers needs.
In this webinar, you will learn:
● How ADC manufacturing has evolved over the past decade
● The challenges that this evolution implies
● Why an integrated supply chain has become increasingly important for the success of ADC projects
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
From preclinical to commercial: The evolution of ADC manufacturing expertise ...MilliporeSigma
ADCs have evolved since the initial approval of MYLOTARG® in 2000, with respect to both conjugation, linker and toxin chemistries as well as processing. With the current availability of four commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain to make manufacturing efficient. With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.
MilliporeSigma has been involved with the development and manufacturing of ADCs since 2008. This webinar will discuss how chemistry and manufacturing have evolved over the past 10 years globally and how MilliporeSigma, as a CDMO has adapted to these changes to meet customers needs.
In this webinar, you will learn:
● How ADC manufacturing has evolved over the past decade
● The challenges that this evolution implies
● Why an integrated supply chain has become increasingly important for the success of ADC projects
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
By choosing Covance as a single, centralized CMC analytical laboratory, you can obtain higher quality analytical data more efficiently and at lower cost/fewer resources than by working with multiple providers/CMOs. This analytical data is the key to knowledge and quality risk management throughout the product lifecycle.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Commrcialization is the process of bringing new product to services to market . The broader act of commercializ
Commercialization is the process of bringing new product to services to market. The broader act of commercialization entails production, distribution, marketing, sales, customer support, and other key function critical to achieving the commercial success of the new product or service.
Global Pharmaceutical (CRAMS) Contract Research And Manufacturing Services Provided by AMRI - Mr. Prashant Salve - AGM (Global Business Development) Email: prashant.salve@amriglobal.com
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
#Stabicon product certification process management strives to improve processes and align the needs of regulatory with client objectives on quality product distribution channel. This gives transparency to the process making it more efficient. It include review and testing process to validate that certified products meet certain standards and comply with a stated designed specification/requirement. Product certification process works towards improving efficiency across the various project stakeholders by helping product evaluation and implement best practices.
Biopharmaceutical include vast range of proteins which can be modified at a molecular level and used in artificial vaccines, nutraceutical products and various product on a large scale.
n Ayurveda, withania is widely claimed to have potent aphrodisiac, sedative, rejuvenative and life prolonging properties. It is also used as a general energy-enhancing tonic known as Medharasayana, which means 'that which promotes learning and a good memory' and in geriatric problems.
A growth strategy is an organization's plan for overcoming current and future challenges to realize its goals for expansion. Example of growth strategy goals include increasing market share and revenue, acquiring assets, and improving the organization's products or services.
#FormulationDevelopment is as much an art as it is a science, and it's the people that make the difference. Each of the technologies we work with has application two or more dosage forms and multiple routes of administration. Of course, we have all the analytical and production support needed to advance these products into the clinic. For more details please visit on: http://www.stabicon.com/formulation_Development.php
#Imported or Locally Manufactured #medicines without proper pre & post inspection may be rendered substandard at any point along the #medical supply chain, from the point of manufacture through the point of distribution. Regardless of where along the supply chain substandard #medicines are compromised, they pose serious public health risks. for more details please visit on:http://www.stabicon.com/
#Stabicon has been ambitiously established in 2010. Stabicon has a broad range of capabilities and networks in the industry with over 100+ clients and 450+ completed projects for improving our industry partners' growth & human health benefits. Our decade-old experience includes supporting pharmaceutical companies & Institutes for #dosage conversion, Process # #health quality, Cost efficiency & Turnaround time for their stringent regulatory markets products filing to get market authorization. we are proud to lay a #foundations for prosperous future in prevention and cure segment, future #medicine & #FMCG business.
For more details please visit on:http://www.stabicon.com/
Stabicon Life Sciences’ Innovative Solity 3p™* proprietary product technology platform. It enables a wide set of industry and function specific solutions that allows our customers to elevate productivity and create value.
In vitro studies are critical to drug and wellness product development due to their ability to provide a basis for clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology development of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established.
Orally Inhaled & Nasal Drug Products: delivery systems, components and specialist services for a growing industry sector” This edition is one in the series of ONdrugDelivery publications.
Nutraceutical product is a food or fortified food product that not only supplements the diet but also assists in treating or
preventing disease (apart from anemia), so provides medical benefits. Nutraceuticals are not tested and regulated to the extent of pharmaceutical drugs…
In Ayurveda, Withania is widely claimed to have potent aphrodisiac, sedative, rejuvenative and life prolonging properties. It is also used as a general energy-enhancing tonic known as Medharasayana, which means ‘that which promotes learning and a good memory’ and in geriatric problems .
Imported or locally manufactured medicine without proper & post inspection may be rendered substandard at any point along the medical supply chain, from the point of manufactured the point of distribution. Regar4dless of where along the supply chain substandard medicines are compromised, they pose serious health risks.
We express our gratitude and thank you for being the part of our journey through 10 years. without it would not have been possible. We believe in touching lives by providing good quality of life and wellness. You are the witness to our diversification and venturing into future segments of therapeutic and FMCG.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience spans across from design to concept, lab to commercialization of product and with competent technical experts. Automated Process driven and prepared for integration with partner site for transparency and real time access on each application.
Biopharmaceutical include vast range of proteins which can be modified at a molecular level and used in artificial preparation of vaccines, nutraceutical products and various products on a scale. Biopharmaceuticals are usually derivatives of natural human proteins, which make them ideal for targeted cellular therapy. Unlike small molecule drugs, which penetrate cell membranes including healthy cells, Biopharmaceuticals act through external cellular binding to induce the desired cellular response.
Ability to work in joint ventures and across divisions, culture and countries. Ability to integrate an understand of IP. Scientific expertise and business strategy. Ability to spur creativity while managing commercially. Expertise in functioning and decision making of regulatory requirement. Human resource skills to transform pharmaceutical segment. Dedicated support systems for web interface with real time information. Quality system must meet regulation in multiple markets plus clients internal standards.
Stabicon has evolved with vast experience in working with MNCs and diversified its business portfolio into specialization in managing product quality process, upgrading, introducing advanced technology into products and manufacturing. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. For more details please visit the link http://www.stabicon.com/blog/2020/11/13/strategic-growth-process/?preview_id=106&preview_nonce=7affa7312c&preview=true
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
2. Overview
2017 2
• Located in Bangalore, a Dedicated cGMP and cGLP Compliance
Laboratory
• Established in September 2010
• Approved Contract research Organization by India FDA
• Approved by Health Canada since 2013
• Registered with USFDA & DSIR
• Managed by well experienced professionals from Multinational Companies
and Contract research organization
• In the business of Formulation R&D, Invitro,Analytical Development,
Validation & Stability Management Programs.
3. Management Team
2017 3
Mr. Suresh Khanna
Founder Chairman
Mr. Vijay Kumar Ranka
Managing Director
Over 35 years experience in the pharmaceuticals industry
Set-up one of the largest contract manufacturing company in India
and catering to customers like GSK Pharma, GSK Consumer,
Novartis, J&J, Pfizer, Wyeth, etc…..
Former member of the board of Millipore India
Founder of KPO providing back-office regulatory services to MNC’s in
Europe
Worked in area of transgenic using Micro-injection, Data curation in
disease pathway identification, Bio-analysis, Impurity identification,
Metabolite identification, Enzyme based assays, Characterization of
biopharmaceuticals and Herbals marker identification.
Past positions at NCBS, Jubilant Biosys, Synchron Research &
Waters Corporation.
4. Regulatory Compliance Status
2017 4
• Approved by Health Canada . Recently successful audited and awaiting for
approval letter
• Accredited by NABL (National Accreditation Board for Testing & Calibration
Laboratories) – India as per ISO / IEC 17025:2005
• Approved by WHO, Geneva; under Prequalification Medicine Program –
Procedure for Assessing the Acceptability, in Principle of QC Laboratory
5. Quality Management System
Quality Manual (QM) based on
• ISO 17025 : 2005
• WHO GPQCL
• USFDA 21 CFR Part 210 / 211
• MHRA / EMEA
• Division – 2 of FDR, Health Canada
• Our Quality Strategies
• Our Businesses Process
2017 5
ISO /IEC
17025
Standard Operating
Procedures
WHO
cGLP / cGMP
21 CFR Part
210 / 211
Quality
System / Assurance
Procedures
Quality
Manual
6. Project
Management
& CRM
Formulation
R&D
QC Laboratory
Chemical
&
Instrumentation
STABILITY MANAGEMENT
Microbiology
Lab &
In-Vitro
Sample
Registration
Sample
Archival
Data
Archival
Quality Assurance
Data
Review
&
Issue of
COA
QMS
&
Regulatory
Compliance
Customer
Complaints
&
Investigations
Management
Organogram
Business
Development
Finance &
Administration
Solid
Oral
Liquid
Oral
Topical
Dosage form
2017 6
7. Facility Highlights
Independent
building,
4 levels,
18,000 sq. ft.
Built-up area
Segregated
facilities for
Instrumentation,
Wet Chemistry,
Microbiology.
Stability Project
Management
Dedicated
Facility for
Formulation
Development
(Tablets,
Capsules,
Liquid
Orals,etc..)
Captive
Power
Generation
&
Support
Fully
Compliant
with EHS
Regulations
2017 7
8. Product Development - Highlights
2017 8
• Development & business Strategy
• Project Timelines and mile stones monitoring
• Administrative licensing activities
• API / Excipient / Packing materials sourcing and vendor screening
• Patent non infringement for formulation
• Formulation trials for robust composition as per QbD.
• Scale up and process optimization and stability
• Quality risk assessment and Quality attributes
• Process Validation
• Dossier documentation as per CTD requirements
• Customer communication and building transparency, confidence and
buoyancy
9. Laboratory Highlights
• Stability Projects are monitored & maintained using Validated LIMS
Software
• HPLCs & UPLC are on Central Net-working Software in compliance with 21 CFR
Part 11
• Stability Chambers & Incubators Data Monitoring using validated
ICDAS Software
• All Analytical Equipment data back-up done periodically on Dedicated Server
• RO Water Purification
System
• Access Control Systems
• Fire Alarm Systems
• Smoke Detection Systems
2017 9
10. Laboratory Services Offered
• Stability Programs
• Analytical Development & Validation
• Bio-waiver Studies (Comparative Dissolution Profiles)
• Invitro Bio Equivalent studies
• Quality Control Testing
• Microbiological Testing
• Sterility Testing closed system (Isolator integrated with sterility test pump Millipore)
2017 10
11. Stability Programs
ICH Compliant
Storage Chambers
25°C/ 60%RH
30°C/ 65%RH
30°C/ 75%RH
40°C/ 75%RH
Photo-stability
24/7
Data Monitoring,
Mobile Alert Systems
& Engineering
Team
Chambers & Software
Qualified as per
21 CFR part 11, ICH
&
GAMP-V
Guidelines
Current Capacity
55,000 Liters
Scalable to 200,000
liters
To accommodate
6000 to 25000
Batches
2017 11
• Long-term Stability Studies
• Accelerated Studies
• Photo-stability Testing
• Zone IV Conditions
• Freeze Thaw Stability
• Customized Study
12. Stability Programs
2017 12
We undertake Stability Programs of
• R&D & Pilot Batches
• Process Optimization Batches
• Validation Batches
• Follow-up Batches
• Commercial Batches
• On-Going Batches
13. Method Development & Validation
• Verification of Accuracy & Adoptability of the Developed Method
• Development & Validation of Stability Indicating Methods
• Analytical Method Transfers
• Re-validations / Partial Validations As Per Customer Requirement
• As per requirements of ICH, USFDA, MHRA, MCC, WHO, ANVISA, etc..
2017 13
• Assay
• Dissolution
• Uniformity of Content
• Related Substances
• Degradation Products
• Identification
• Purity
• Preservatives
• Anti-oxidants
• Colourants
• Method Development & Validations for
14. Biowaiver Studies
• Development of
Dissolution Methods
• Performing CDPs
2017
14
Discriminating
as per various
Regulatory Requirements like WHO,
USFDA, MHRA, TGA, MCC, ANVISA,
etc…
• Conclusions based on Classification
of Drug Molecules
• F1 / F2 calculations for acceptability of
Bio-waivers
15. Pre-Despatch QC Testing
• Raw Materials (Exceipients / APIs)
• Oral Solid Dosage Forms
• Oral Liquid Dosage Forms
• Ointments / Creams / Gels / Soft Gels
• Sterile Products
• Ophthalmic Products
• Cosmetics Controlled By FDA
• Pharmaceutical Water Analysis
2017 15
16. Microbiology
• Validation of Microbiological Tests
• Bio-burden Tests
• Bacterial Endotoxins by LAL
• Antibiotic Assay
• Preservative Efficacy Testing
• Efficacy Testing of Antibiotic Activity
• Efficacy of Chemical Disinfectants
• Environmental Monitoring
2017 16
17. In-Vitro Bioequivalence studies for following areas, but not limited to it. It is always
open to discuss to new approaches and new challenges.
• In-vitro Binding Studies for Locally acting GI Resin Drugs
• Oral Generic Product with An Alternate Administration
• In-Vitro Quantitative Capsule Rupture Test (QCRT)
2017 17
In-vitro Bioequivalence
18. Clientele
2017 18
Customer from Pharmaceutical industry & Health organization from highly
regulated markets like USA, Canada, UK, EU Countries & South Africa.
a) South Korea,Russian, CIS, Middle East & Developing countries
• Approved by leading generic pharmaceutical and MNC’s
19. Why Stabicon ?
2017 19
• Conceptualized Project Management
• Robust Regulatory Documentation
• Assured Confidentiality on Product Technology & Data
• Well Experienced Professionals who add value to your thought
process by understanding your needs during Product Development, Validations
and Dossier Registration till receipt of MA
• We deliver to International Quality Standards at Competitive
costs
• Open for Transparency like Data interface through Web-access
20. Thanks
For any query, Please
contact us
Stabicon Life Sciences Pvt. Ltd
Corporate office : No 41 Nandi durg Road, Jayamahal Extension,
Bangalore – 560046
Phone :+91 8041285405
R & D Centre :Plot No. 28,
Bommasandra Industrial Area (Sub-layout), 4th Phase, Jigani
hobli, Anekal Taluk, Bangalore - 560 100 (INDIA)
Phone: +91 80 2783 9259 / 60
e-mail : info@stabicon.com
Website: www.stabicon.com
2017 24
