What Are The Roles Of Regulatory Affairs Professionals?

1.	What Are The Roles Of Regulatory Affairs Professionals?
Answer» Act as a liaison with regulatory agencies. Preparation of organized and scientifically valid NDA, ANDA,INDA ,MAA,DMF submissions. Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws. PROVIDING expertise and regulatory intelligence in translating regulatory REQUIREMENTS into practical workable plans. Advising the COMPANIES on regulatory aspects and CLIMATE that would affect their proposed activities. Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.

Answer»

Act as a liaison with regulatory agencies.
Preparation of organized and scientifically valid NDA, ANDA,INDA ,MAA,DMF submissions.
Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws.
PROVIDING expertise and regulatory intelligence in translating regulatory REQUIREMENTS into practical workable plans.
Advising the COMPANIES on regulatory aspects and CLIMATE that would affect their proposed activities.
Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.

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