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