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