Preparing for a USFDA Inspection and managing the post inspection situation requires a high level of expertise and PharmSol offers a comprehensive solution in that direction.
Compliance Management
Preparing for a USFDA Inspection and managing the post inspection situation requires a high level of expertise and PharmSol offers a comprehensive solution in that direction through:
- Facility Design and Upgrade
- Quality System Design and Upgrade
- Gap Analysis Audits
- Mock Inspections
- Specialized Training for Inspection
- Post Inspection Remediation (483s / Warning Letters)
- Ongoing compliance monitoring
Product Development
PharmSol facilitates Product Development with focused approach to US Market by offering solutions in line with:
- Development of Candidate Selection / Strategy
- Selection of right API
- QbD Guidance
- Technology Development Support (API / FDF)
- IPR Support including access to US Attorneys
- BE Studies Coordination (CRO Selection, RLD Procurement, BE Study Protocol Design and Review, Monitoring)
- Efficient (time & cost) Project Management
Regulatory Support
PharmSol with its team of Regulatory Experts and local agents can facilitate regulatory submissions as well as liaise with the Agency.
- Data Analysis
- DMF, ANDA Preparation / Review / Compilation
- Focus on avoidance of RTR situations
- DMF / ANDA Submission (incl. US Agent)
- Deficiency Answering
- Track on Approval Process
- Competition Watch
BD Support
With increase in the market competition, understanding and evaluating the market trend is a must considering the investments involved.
- Pipeline evaluation & Product selection
- Patent landscape review
- Generic activity monitoring
- Early entry strategies
- US marketing partner selection and tie up
- Co-development opportunities
- Early licensing opportunities
- Post-approval support and SCM
Interested? Want to know more? Kindly contact us…
Our Establishments
PharmSol GmbH
Bad Oldesloe, Germany
PharmSol Europe Limited
Mosta, Malta
Pharmaceutical Solutions FZCO
Jebel Ali, Dubai, United Arab Emirates
Pharmaceutical Solutions DMCC
Jumeirah Lake Towers, Dubai
PharmSol Egypt
Heliopolis, Cairo, Egypt
PharmSol India Pvt. Ltd.
Hyderabad, India
PharmSol (Nanjing) Pharmaceutical Technology Co.Ltd
Nanjing City, Jiangsu Province, PR China
PharmSol APAC Limited
Hong Kong, China
PharmSol-Pharmaceutical Products Trading
Makati City, Philippines
PharmSol Europe Limited (Rep. Office)
Ho Chi Minh City, Vietnam
