RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
Format : CTD (Common Technical Document)
Upon request we can also give DMF in ACTD format
Table of content
CTD Introduction
Quality Overall Summary
S.1 General Information
S.2 Manufacture (ROS)
S.3 Characterisation
S.4 Control of Drug Substance
S.5 Reference Standards or Materials
S.6 Container Closure System
S.7 Stability
- Registration Application, Letter of Authorisation & Covering Letter
- Legal & Administrative Documents
- Transmittal letter
- Global Patent Information and Literature for patented API
- Patent infringement analysis
- Quality Summaries, Manufacturing and Characterization part of DMF
- Process validation, AMV & Stability Studies
- Specification, Method of analysis & Certificate of Analysis of Raw materials
- Specification, Method of analysis & Certificate of Analysis of API
- Experienced Team – Our consultants had vast experience in DMF preparation and review
- Our consultants - previously worked in Top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin etc
-Handling all MoH Queries related to DMF (till product registration)
- DMF review as per CTD
- More than 1200 CTD DMF templates
(Ready-to-write : to save time)
- Reference US & EU – 600 DMFs
Format : CTD (Common Technical Document)
Upon request we can also give DMF in ACTD format
S.2 Manufacture
S.2.1 Manufacturer (s)
S.2.2 Description of Manufacturing Process and Process Controls
S.2.3 Control of Materials
S.2.4 Controls of Critical Steps and Intermediates
S.2.5 Process Validation and/or Evaluation
S.2.6 Manufacturing Process Development
- Experienced Team – Our consultants had vast experience in DMF preparation and review
- Our consultants - previously worked in Top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin etc
-Handling all MoH Queries related to DMF (till product registration)
- DMF review as per CTD
- More than 1200 CTD DMF templates
(Ready-to-write : to save time)
- Reference US & EU – 600 DMFs I
- Registration Application, Letter of Authorisation & Covering Letter
- Legal & Administrative Documents
- Transmittal letter
- Global Patent Information and Literature for patented API
- Patent infringement analysis
- Quality Summaries, Manufacturing and Characterization part of DMF
- Process validation, AMV & Stability Studies
- Specification, Method of analysis & Certificate of Analysis of Raw materials
- Specification, Method of analysis & Certificate of Analysis of API
- Highest quality @ reasonable price
- Confidentiality and On-time delivery
- Complete DMF solution
- Regulatory expertise -Dedicated DMF professionals (Knowledgeable & Experienced)
- Complete regulatory assistance on DMF queries upto the product registration stage
- Since 2008, Over 11 years of experience in global regulatory environments
- Our regulatory affairs (Dossier & DMF) service facility Area is about 33,000 sft at APIIC, Madanapalle, AP.
- We have most Advance and Sophisticated equipment
- High quality Database (Template & reference DMF)
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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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