Dossier - CTD, ACTD & ROW
Fides Regulatory is a global leader in regulatory consulting and dossier solution for export registration
We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline)
Email your Dossier requirements to dhaarmi@fidesregulatory.com/ fidesraa@gmail.com - We will review your requirements and revert back to you ASAP. And will also provide Quote / sample Dossier Index on demand
PREPARE, REVIEW AND SUBMIT
Format : CTD Guideline (EU / ICH / RoW)
Module 1 - Administrative Information and Prescribing Information
Module 2 - CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
Module 3 - Quality (S part - DMF & P Part - Finished Product)
Module 4 - Nonclinical Study Reports (Literature-Based)
Module 5 - Clinical Study Reports (Literature-Based)
WRITING / REVIEW
-Registration Application & Covering Letter
- Letter of Authorisation
- Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert
- Label and carton contents
- Global Patent Information and Literature for patented product
- PSUR (Periodic Safety Update Reports)
- Legal & Administrative (GMP,CoPP, FSC etc) Documents
-Expert Summaries
- Site Master File (SMF)
SUPPORTIVE SERVICES
-Handling all MoH Queries (till product registration) and Review Dossier as per Updated MOH guideline
- Advising on translation
- Agreements Writing & Review (CDA/NDA & Supply)
- DMF (in CTD format)
- Advice on BE studies
-Drafting Process validation, Stability, PDR & AMV
- More than 600 CTD Dossier templates
(Ready-to-write : to save time)
- Reference Dossiers / DMFs/ BE Database
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
