Regulatory & Dossier Support

Our strength is a team of consultants with experiences ranging from 10-15 years in regulatory services in regulated and non regulated markets, competence in Human medicines, Veterinary medicines, medical devices, Herbal drug and Dietary supplements.
Our Commitment is total confidentiality; time bound submissions and providing regulatory support till the product is registered and marketed.

Our Compilation of dossier as per latest country specific guidelines

Dossier compilation as per:

  • ASEAN Common Technical Dossier (ACTD) Guidelines
  • South Africa (MCC-MRF-1) Guidelines
  • Brazil ANVISA Guidelines
  • G.C.C countries

Dossiers (CTD) compilation for submissions in:

  • Asia
  • Africa
  • Middle East
  • Central America
  • South America
  • North America

Dossier compilation in Common Technical Dossier (CTD) format and Conversion to eCTD for:

  • US FDA
  • Saudi FDA
  • European counties

DMF (Drug Master File):
We have associated with NABL Certified well established labs to carry out analytical testing.

We also perform the following studies, in co-operations to DMF preparation:

  • Structural Elucidation Studies
  • Analytical Report (COA)
  • Analytical Method Validation
  • Process Validation
  • Stability data studies
  • Determination & Validation of Potential Impurities & Solvent Impurities

(All the data supported by necessary Chromatograms & Spectrums)

Prepare Summary of product (SPC), Pack Insert, Product rationale.

Expert Reports

  • Quality
  • Pre-clinical
  • Clinical

Nonclinical Study Reports (Module 4)
Clinical Study Reports (Module 5)
Dossier conversion (from one country to another) and

Registration Assistance:

  • Worldwide Regulatory Consultation of Human medicines
  • Worldwide Regulatory Consultation of Veterinary medicines
  • Worldwide Regulatory Consultation of Medical Devices
  • Worldwide Regulatory Consultation of Food
  • Worldwide Regulatory Consultation of Dietary Supplements
  • Worldwide Regulatory Consultation of Herbal Drugs