RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
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)
-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)
-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
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)
-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
-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
We prepare & review dossier as per country specific guideline.
ROW Dossier cover below parts
- Administrative and legal Part
- Quality Part
- Clinical and Toxicity Part
-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
-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
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Bangalore
PDDS
Zodiac Building, Third Floor, # 33, EWS, 8th Cross, Kengeri Satellite Town,
Bangalore, Karnataka,
PIN 560 060 India
Mumbai Office
Plot Number 78, SH Tower CHS, Jalvayu Rd, Sector 20, Kharghar, Navi Mumbai, Maharashtra 410210 India
Pragya Dossier-DMF Services
Plot No. 63, 76 & 77,
Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, India
GSTN: 37AHNPT4410B1ZG
Email: info@pdds.in
Phone : +91 - 965 228 1814
Web: www.pdds.in
For Instant Quote:-
+91 - 965 228 1814 (whatsapp)
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