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Dossier Services

 INDIA'S MOST RELIABLE & RECOMMENDED
DOSSIER PROVIDER

Zodiac Pharma is a Global Leader in Regulatory Consulting and Dossier (CTD, ACTD & ROW Dosssier) Solution 

Dossier - CTD, ACTD & ROW

Zodiac Pharma 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 info@zodiacpharma.com - We will review your requirements and revert back to you ASAP. And will also provide sample documents 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  

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Our Happy Clients

More than 120 Satisfied Global Clients

Address

Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, IN

GSTN: 37AAAFZ9801C1Z7

Contact Us &  

Email: info@zodiacpharma.com Phone: +91 - 832 847 9767
              +91 - 965 228 1814
Web: www.zodiacpharma.com 

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