YES ! WE CAN
FIDES RAA provides effective global Regulatory Affairs services for all stages of Pharmaceutical, API and other health product development and lifecycle management. Reliable Regulatory Partner
INTERDISCIPLINARY TEAMS
Our highly motivated workforce includes regulatory affair (Dossier / DMF) consultants, scientists, trainers, doctors and industrial partners. Our team members previously worked in Top Indian companies like DRL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin etc
EXTENSIVE INTERNAL RESOURCES
We have experience of compilation, review, drafting of 764 Dossiers (SEMI REGULATED & RAW MARKETS), 2250 DMF (VARIOUS GRADES FOR ACROSS GLOBE), 89 BE, compilation, review and many ROW dossiers and DMFs. Other many Technical Documents handling experience we have like, AMV(More than 1650), SMF, PVP-PVR, PDR, PSUR, PV, SOP. This work helps us to maintain our position as a provider of the highest quality services and the best registration dossiers partner.
OFFICES & IN-HOUSE DOSSIER/ DOCUMENT FACILITY
In Ahmedabad & Surat India, we are having special Dossier delivery team (more than 10 people working at any time). Our dossier service facility Area is about 4500 feet at Surat City. We have most Advance and experience people for Dossier compilation.
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
