Medical Writing

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Medical Writing

Production, Generation & Submission of Aggregate Reports (PBRERs, PADERs, ASRs & DSURs)

  • Production of Product Specific Line Listings.
  • Complete authoring and production of PEBRERs/PSURs, PADERs, DSURs, Addendum to Clinical Overview (ACO).
  • Compliant Formats: ICH E2C, GVP Modules; US FDA CFR Part 314.80.

Risk Management Plans / REMS

  • Authoring and preparation of EU RMPs and REMS.
  • Help & Support with preparation of Medication Guides, Educational Materials and other Risk Minimisation Plans.
  • Help & Support with Survey and testing as a measure of effectiveness of RMP/REMS with patients and prescribers.

Labelling: IB; SmPC, PIL, CCDS & USPI

  • Preparation and authoring of labelling documents and Reference Safety Information for products (CCDS, SmPCs, IBs, PILs)

Other Medical Writing Services

  • ICSR Narratives—Company Assessment & Comments
  • Causality Assessments
  • Risk Benefit Assessments
  • Analysis of Similar Events
  • Integrated Safety Summary (ISS)
  • NDA Clinical Report Safety Sections
  • Patient Profiles for Different Phases
  • Preparation of Clinical Overview & Clinical Summary
  • Preparation , authoring & maintenance of PSMF
  • Phamacovigilance Plans
  • Dear Doctor & HCP Letters