1560 Holden Street San Diego, CA 92139

KING OF DOSSIER FOR INDIAN PHARMACEUTICALS PLAYERS

LARGEST TEAM AND QUICKEST DOSSIER PROVIDER, WE ASSURE FOR DELIEVARY OF DOSSIER EVERY THIRD DAY

Technology

Right Manufacturing Process = Advantages in Export
Email your product technology requirements to dhaarmi@fidesregulatory.com/ fidesraa@gmail.com - We will review your requirements and revert back to you ASAP. And will also provide sample documents on demand.

Technology

Best Quality - Tech transfer - Reasonable Price Product technology includes:
- Batch formula, MFR, BMR

3.2.P.2.1 Components of the Drug Product - Drug Substance & Drug Product
3.2.P.2.3 Manufacturing Process Development
3.2. P.2.4 Container closure system
3.2. P.2.5 Microbiological attributes
3.2. P.2.6 Compatibility

Dosage form

Solid, Semi-solid, Liquid
Tablets (IR & Modified)
Capsules (Hard & Softgel)
Ointment / Gel
Solution & Powder for Injection
Oral liquid / Suspension / Powder
Aerosol (inhaler)

WHY YOU CHOOSE US

-Validated & Bioequivalent Product Formula and Process
- F&D Professionals (Knowledgeable & Experienced)
- High quality Database (Reference US / EU approved technology)
- Since 2008, Over 11 years of experience
- Highest quality @ reasonable price
- Confidentiality and On-time delivery

PREPARE, REVIEW AND SUBMIT 

Format : ASEAN CTD Guideline 

Part I - Administrative Information and Product Information
Part II - Quality (S part - DMF & P Part - Finished Product)
Part III  - Nonclinical Study Reports (Literature-Based)
Part IV  - Clinical Study Reports (Literature-Based) 

WRITING / REVIEW


-Registration Application & Covering Letter
- Letter of Authorisation
- Summary of product (SmPC)
- PIL or Pack insert
- Label and carton contents
- Legal & Administrative (GMP,CoPP, FSC etc) Documents
- Expert Summaries
- Site Master File (SMF)
- Process validation, Stability, PDR & AMV, BE

SUPPORTIVE SERVICES

-Handling all MoH Queries (till product registration)
- Review Dossier as per Updated ASEAN guideline
- Agreements (CDA/NDA & Supply)  Writing & Review
- Separate DMF (in CTD / ACTD format)
- More than 600 ACTD Dossier templates
(Ready-to-write : to save time)
- Reference ACTD Dossiers / DMFs / BE Database 

PREPARE, REVIEW AND SUBMIT

We prepare & review dossier as per country specific guideline.

ROW Dossier cover below parts
- Administrative and legal Part
- Quality Part
- Clinical and Toxicity Part 

WRITING / REVIEW

-Registration Application & Covering Letter
- Letter of Authorisation
- SmPC, PIL or Pack insert
- Label and carton contents
- Legal & Administrative (GMP,CoPP, FSC etc) Documents
-COA, MOA and Specification of Active, Non-active and Finished Product  
- Process validation, Stability, PDR & AMV, BE studies
- BMR / MFR
Clinical and Toxicity studies

SUPPORTIVE SERVICES

-Handling all MoH Queries (till product registration)
- Review Dossier as per Updated MOH guideline
- Agreements Writing & Review
- Separate DMF (in CTD format)
- Reference Dossier templates (updated) - For more than 60 country specific templates
(Ready-to-write : to save time)
- Reference Dossiers / DMFs / BE - Database  

Our Happy Clients

More than 230 Satisfied Global & Indian Clients