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What is the toughest part about regulatory affairs?

Regulatory Affairs
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Question added by Rana Alnajjar , Web developer , Lebcards
Date Posted: 2013/06/26
Upvote (0) Views (14) Followers (0) Answers (6) Report Question
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SAHL HIJAZI
by SAHL HIJAZI , Purchasing Manager , BINZAFRAH GROUP

To deal with standards time for registration process , in addition if your company in hurry to register a product & company R& D made a mistake needs for RE-SUBMMSION

Rawa s

To me it is the periodic amendments and updates to the regulatory pathways and procedures which can be time consuming and in a way costly.

SYED GHAZALI
by SYED GHAZALI , Supply Chain & Operation. Manager , ALLMED FZCO

Most toughest part is changes in procedure and requirement frequently.
which increases the time of registration and more documention and effort needed.

Reem Abdul Qader
by Reem Abdul Qader , Regulatory Affairs Consultant , Al Mutanabbe Drug Store

Being able to fulfill each market's regulations within the specific time scheduled in RA plan

Faisal Matbuli
by Faisal Matbuli , QARA Director - Middle East, Africa, Central Asia & Turkey , Medtronic

Dealing with emerging regulations and new regulators.

Ajay Cherian
by Ajay Cherian , AVP- Regulatory Compliance , FAB

The toughest part of Regulatory Affairs would be to ensure your Organisation does not fall into the bad books of the Regulator and to achieve that you have to be well versed with all the Regulatory Guidelines and instructions that pop up from time to time.

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