• House no. 41, Gurunanak Nagar, baltana, Distt Mohali) ,Punjab. India

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.)


House no. 41, Gurunanak Nagar, baltana,
Distt Mohali) ,Punjab.India
Phone: + 91 -962-564-5858
Phone: +91- 701-893-8101
E-mail: pharmaactddossiers@gmail.com