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Pragya Dossier-DMF Services

RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS

PDR & PV

Right PDR / PV = Less MoH Queries

Email your PDR / PV requirements to info@@pdds.in - We will review your requirements and revert back to you ASAP. And will also provide Quote / index on demand

Product Development Report

We Draft PDR (CTD Format)

PDR includes:

3.2.P.2.1 Components of the Drug Product - Drug Substance & Drug Product
3.2.P.2.3 Manufacturing Process Development
3.2. P.2.4 Container closure system
3.2. P.2.5 Microbiological attributes
3.2. P.2.6 Compatibility

Dosage Form
Solid, Semi-solid, Liquid
Tablets (IR & Modified)
Capsules (Hard & Softgel)
Ointment / Gel
Solution & Powder for Injection
Oral liquid / Suspension / Powder
Aerosol (inhaler)  

Process Valdiation

We Draft Process Valdiation Protocol and Report as per ICH guideline 

PVP - Protocol includes below points:
Purpose of the protocol
Introduction – Objective, Scope, Reason for Concurrent Process Validation, Responsibilities, Reference documents
Description of process, Process flow diagram and Composition
Cleanliness zone requirements
Special precautionary measures
Evaluation of critical process parameters
Sampling plan and acceptance criteria  

PVR - Reports includes below points:
Purpose of Report
Summary of validation activities
Deviations to Protocol
Description of Process, equipment and testing performed
Results and discussions
Additional Testing and deviations
Conclusions 

WHY YOU CHOOSE US

- Validated & Bioequivalent Product Formula and Process 
- F&D Professionals (Knowledgeable & Experienced)
- High quality Database (Reference US / EU approved technology)
- Since 2008, Over 11 years of experience 
- Highest quality @ reasonable price
- Confidentiality and On-time delivery




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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)