Our pharmaceutical regulatory experts can provide training to your employees on several regulatory topics based on ICH, US FDA, and Ph. Eur. Guidelines. The topics we cover are listed below.
| API Regulatory Affairs |
Drug product regulatory Affairs |
- Selection of raw materials, starting materials and intermediates based on Q11 guidance to ensure GMP compliance.
- Creating DMF/ASMF/CEP regulatory dossiers and how to differentiate restricted/closed part from open/applicant part.
- CEP advantages and validity in different territories.
- Setting specification for new APIs and specification based on pharmacopoeial monographs.
- Impurities / related-substances, residual solvents and elemental impurities.
- ICH M7 assessment
- API Stability testing, accelerated stability studies, photostability, evaluation of stability data, Stability conditions for different climatic zones.
- GMP guidelines for API synthesis
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- Pharmaceutical drug product development
- Legal basis of marketing authorisation application in the EU and the US
- Analytical method validation
- Setting specifications
- Impurities / related-substances, residual solvents and elemental impurities.
- Drug prodct Stability testing, accelerated stability studies, photostability, evaluation of stability data, stability conditions for different climatic zones.
- Difference in MA dossiers of drug products that use API with DMF/ASMF and drug products that use API with a CEP
- USFDA ANDA and BLA applications
- EU MA applications: National, MRP, DCP, CP and orphan drugs
- EU variation guidelines: Type IA, Type IAin, Type IB, Type II and change management protocols.
- Concept of bioequivalence
- Biopharmaceutics classification system (BCS)
- Dissolution and disintegration
- Typical analytical tests for solid dosage forms
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