Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing.

 

The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

Main Services:

1. Drug Registration

2. Preparation of Common Technical Document (CTD)

3. Preparation of Electronic Common Technical Document (eCTD)

4. Preparation and updating of Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC).

 

289 Comments

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  99. Once I initially commented I clicked the -Notify me when new feedback are added- checkbox and now each time a remark is added I get four emails with the same comment. Is there any manner you can take away me from that service? Thanks!

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  206. Hiya! I know this is kinda off topic but I’d figured I’d
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  215. Hi just wanted to give you a brief heads up and let you know a few of
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  259. Hey there would you mind sharing which blog
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