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Medical Writing Services




PharmaActdDossiers staff has extensive medical writing experience including Pre-Clinical and Clinical Study Reports, INDs, Fast Track Applications, New Drug Molecules and clinical summaries for Safety and Efficacy, ACTD, CTD and eCTD submission format.

PharmaActdDossiers service offering the following:

Preparation and submission of Regulatory documentation including:

  • PSUR (Periodic Safety Update Reports)
  • PV or PhV (Pharmacovigilance Study Report)
  • BA/BE ( Bioavailability /Bioequivalence) Studies Reports.
  • CSR (Clinical Study Reports)
  • Preclinical reports
  • QMS (Quality Managements System)
  • Expert Reports
  • Regulatory/Quality GAP Analysis.
  • Package Inserts / summary of product characteristic (SmPC)
  • Labeling Protocols     SOPs
  • Risk Management (ISO14971)
  • Regulatory submissions (IND, NDA, DCGI Files, COPP Data & Fixed dose combination etc.)
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