Regulatory Medical Writing Services RELATED PUNCHLINE WILL APPEAR HERE

Regulatory Medical Writing

Medical writing for pharmaceutical industry involves regulatory documentation for regulatory agencies all over the world. Our experts work with a clear vision and their work clearly demonstrates safety and efficacy of the product with our medical writing. PPC expertise in regulatory medical writing can assist companies with the following services.

  • Medical writing for Module 5 – Clinical Documentation
  • Medical Writing for Module 4 – Non Clinical Documentation
  • Module 2.4 to Module 2.7 – Overview & summaries
  • PSURs Reports – Periodic Safety Update Report now called PBRER – Periodic Benefit- Risk Evaluation Report
  • Pharmacovigilance System Setup
  • Risk Management Plans
  • Summary of Product ( SPC), Pack Insert

Analytical Outsourcing

PPC has a wide range of network and tie –ups with Many analytical Labs, CRO, and Hospitals for caring out wide range of Analytical tests , BE Studies, and Clinical Trials. Our Tie- ups and technical expertise helps us achieve efficient work at low cost in timely fashion, which is passed on the customer .

Outsourcing of such technical work to us helps customers in

  • Saving of technical manpower to check and interpret results
  • Saving of time & reduced costs
  • Appropriate testing as per requirement of respective regulatory agencies.

Test we can carry out through our Associates

  • Bio –Equivalence studies for Complex Molecules from US FDA Approved Centers,
  • European Approved centers, DCGI Approved centers, ANVISA Brazil, Turkey MOH, and Thailand FDA.
  • Conduct Clinical Trials as per international and DCGI requirements in Pune and other places in India
  • Toxicological Testing for Pharmaceutical and allied products.
  • Analytical Tests From – NABL Accredited Labs
    • Stability Studies – Long Term – Accelerated
    • Analytical Method Validations
    • Impurity Profiling
    • Elemental Analysis
    • Dissolutions Studies