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
