Services offered

Dossier compilation
  • Common Technical Dossier (CTD) Guidelines (Asia/ latam/ Africa/MENA/ CIS/ EU)
  • Asean Common Technical Dossier (ACTD) Guidelines.
  • Country Specific.Literature Search
Literature search
All Pharmaceutical/ Medical literature search as per client requirements.

Leaflet Preparation
We provide for any region/ county specific leaflets including translation.

Clinical/ Non clinical
  • Overviews (Module 2)
  • Clinical
  • Non-Clinical
  • Nonclinical Study Reports (Module 4)
  • Clinical Study Reports (Module 5)
  • Investigator Brochure
  • Summary of Product cherecterstics (SmPC)
  • Bioavailability / Bioequivalance Studies,
  • Prepare Periodic Safety Update report(PSUR)
  • Preclinical studies like Toxicity, Subacute, Acute, Carcinogenicity, Teratology and Reproduction toxicity.Drug Pricing search

Contact Us
anujmairh@gmail.com

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