USFDA Compliance & Regulatory

Compliance Management

Product Development

Regulatory Support

BD Support

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 Expert and local Agent can facilitate regulatory submission 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, scenario is a must considering the investments involved. PharmSol is rightly placed to offer such Business Support in following areas: