Thin Compliance® is a consultancy service provider in Pharma sector started by Sharad Raizada in January 2023. The consultancy aims at creating a synergy in the field of Pharmaceutical manufacturing and compliance by offering the services that will bring your organisation's quality processes to the Global Standards.
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Our Service Offerings
Manufacturing Support
Facility Set-Up & Review
- Review manufacturing ergonomics
- Compliance to GMP requirements
Handling of Inspections – Regulatory and Customers
- Develop SMEs
- Modulate audit response
- Technology Transfer support
- Interface Tech Transfer protocol
- Monitoring of Technology Transfer activity
- Process scale-up support and evaluation
- Continued monitoring of process
Troubleshooting Generic Solutions
Review of Specific Manufacturing Issues
- Process Optimization
- Yield Improvement
- Defect Trending
- Process Investigations
Review of Specific Quality Issues
- OOS/OOT Results
- Quality Trends
- Response to Market Complaints
- Product Quality Reviews
Process Development & Technology Transfer
- Review of Development Reports
- Preparing Technology Transfer Protocols
- Review of Technology Transfer
- Continuous Process Monitoring
Product Identification & Support to Business Development
- Identify new products to be manufactured
- Identify business partners
- Present facility capabilities
GMP Based Compliance
Defining Review metrics
- Metrics for quantifying manufacturing and Quality systems
Planning and Implementation
- Creating and maintaining an effective structure
Evaluation and Update
- Periodic reports generation
Investigation & Risk Assessment
- Risk based implementation of Quality system
Business Support
Material Sourcing - Finished Formulations, APIs, Excipients
- Identifying & Managing strategic partners – Vendor control
Product Distribution
- Distribution partners for specific regions
Regulatory support and filing for global markets
- Africa, Russia, ROW, US & Europe.
Business Funding
- Equity & Debt
Personnel Development
- Developing and mentoring SMEs
- GMP Training
- Understanding the organization expectations/ thrust areas & bridging the gap in the value system of employees and organization expectations.
About ThinCompliance®
Domain Expertise
The services are managed by a team of experienced professional(s) in Quality Assurance and Quality Control led by Mr. Sharad Raizada, who holds M.Tech degree from IIT Delhi, with over 32 years of experience in Pharma industry spanning Dosage forms, API, Excipients and Fermentation.
Key highlights of his career path:
- Successfully handled regulatory inspection of US-FDA, TGA, WHO (Geneva).
- Held various leadership and senior quality management positions in Ranbaxy (Sr. Manager), Arch Pharmalabs (Vice President), Zydus Lifesciences (Sr. General Manager) and Lonza (Director). Was part of the Company leadership team in last three assignments.
- Worked as a consultant for quality systems and regulatory thrust for a start-up pharma OTCC manufacturer.
- Domain expertise in Quality systems & compliance, operations, technology transfers in APIs, Pharma OTC, Nutraceuticals and Fermentation products.
- Keen understanding of business commercials.
Mr Raizada's Professional Engagements
Consultant in OSD Softgel Pharma and Nutra business. | Mar. 2022 to Dec. 2022 |
Director Quality (Capsugel|Lonza) | Nov. 2015 to Mar. 2022 |
Sr. General Manager CQA (Cadila Healthcare) | Nov. 2014 to Nov. 2015 |
AVP – QA and Compliance (Arch Pharmalabs) | Sep. 2009 to Nov. 2014 |
General Manager–Corporate QA (Unimark Remedies) | Feb. 2008 to Aug. 2009 |
Senior Manager Corporate QA (Ranbaxy Labs Ltd.) | Jul. 2007 to Jan. 2008 |
Senior Manager Quality Assurance (Plant at RLL) | Apr. 1997 to Jul. 2007 |
Quality Operations Officer (Pfizer India Ltd.) | Apr. 1990 to Mar. 1997 |