Training
Innovative Method of Training
Reliable & Knowledgeable Consultant
Email your Training requirements to info@zodiacpharma.com - We will review your requirements and revert back to you ASAP. And will also provide sample documents on demand.
Training Programs
Training Programs
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,
Executives.
Quality Practitioners and any member
of a pharmaceutical and related industry, those
from Research and Development, IPR, QC, Production, Packing Department,
TOPIC
(For Seminar, Conference / Workshop)
Broad Topic
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
Micro Topic
SMPC, PIL, Pack insert
Preparation & Review of Agreements
Expert review
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.
WHY YOU CHOOSE US
- 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
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
