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

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