USFDA Compliance & Regulatory

Die Vorbereitung auf eine USFDA-Inspektion und das Management der Nachkontrolle erfordert ein hohes Maß an Fachwissen und PharmSol bietet eine umfassende Lösung in diese Richtung.

Compliance Management

  • 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:

  • Pipeline Evaluation and 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

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Unsere Unternehmen

PharmSol GmbH

Bad Oldesloe, Germany

PharmSol Europe Limited

Balzan, Malta

Pharmaceutical Solutions FZCO

Jebel Ali, Dubai, United Arab Emirates

Pharmaceutical Solutions DMCC

Jumeirah Lakes Towers, Dubai, United Arab Emirates

PharmSol India Pvt. Ltd.

Hyderabad, India

PharmSol (Nanjing) Pharmaceutical Technology Co.Ltd

Nanjing City, Jiangsu Province, PR China

PharmSol APAC Limited

Hong Kong, China