RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
Location :- Client chosen place or at our facility
Best in Class
Nowadays it is necessity of every company.
Training Program Photos
The aim of our Training Programs is to provide an in-depth
understanding of regulatory affairs roles in the work place.
Our training program consists
of principal modules and Question & Answer sessions.
Who Should Attend
Key Personnel in any Aspect of Regulatory affairs
& Quality Assurance, Directors, Managers,
Quality Practitioners and any member
of a pharmaceutical and related industry, those
from Research and Development, IPR, QC, Production, Packing Department,
(For Seminar, Conference / Workshop)
CTD Dossier - Preparation and Review
Asean CTD Dossier - Preparation and Review
Open & Closed DMF - Preparation and Review
Marketing Strategy to enter new market
Trick to Handle / Avoid MOH queries
Administrative Document - Preparation and Review
Technical Document - Preparation and Review
BE - Bio wavier & Comparative Dissolution
SMPC, PIL, Pack insert
Preparation & Review of Agreements
Overviews - Quality, Non-clinical and Clinical
DMF - ROS, SA, RS, AMV, SS & COAs
PDR, Process validation, MFR / BMR
RM, PM, FP - Spec, MOA & COA
AMV- Assay, Disso & RS
Stability Studies, BE, Samples
Our Training materials are best in class & industries. We customized training program / training materials as per customer need.
- Complete & relevant training materials
- Dedicated Trainer (Knowledgeable & Experienced)
- Innovative method of training
- Industrial examples with discussion
- Discussion on routine problem and how to solve them
- Training batch - Less number of Participants - Quality discussion
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