amp template

Pragya Dossier-DMF Services

RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS

Dossier - CTD, ACTD & ROW

PDDS 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@pdds.in - 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  

MOBILE FRIENDLY

No special actions required, all sites you make with Mobirise are mobile-friendly. You don't have to create a special mobile version of your site, it will adapt automagically.

MOBILE FRIENDLY

No special actions required, all sites you make with Mobirise are mobile-friendly. You don't have to create a special mobile version of your site, it will adapt automagically.

MOBILE FRIENDLY

No special actions required, all sites you make with Mobirise are mobile-friendly. You don't have to create a special mobile version of your site, it will adapt automagically.

IT'S EASY AND SIMPLE

Cut down the development time with drag-and-drop website builder. Drop the blocks into the page, edit content inline and publish - no technical skills required.

IT'S EASY AND SIMPLE

Cut down the development time with drag-and-drop website builder. Drop the blocks into the page, edit content inline and publish - no technical skills required.

IT'S EASY AND SIMPLE

Cut down the development time with drag-and-drop website builder. Drop the blocks into the page, edit content inline and publish - no technical skills required.

TRENDY WEBSITE BLOCKS

Choose from the large selection pre-made blocks - full-screen intro, bootstrap carousel, slider, responsive image gallery with, parallax scrolling, sticky header and more.

TRENDY WEBSITE BLOCKS

Choose from the large selection pre-made blocks - full-screen intro, bootstrap carousel, slider, responsive image gallery with, parallax scrolling, sticky header and more.

TRENDY WEBSITE BLOCKS

Choose from the large selection pre-made blocks - full-screen intro, bootstrap carousel, slider, responsive image gallery with, parallax scrolling, sticky header and more.

Our Happy Clients

More than 150 Satisfied Global Clients

Address

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

Dossier Developing Unit 

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)