REGULATORY AFFAIRS

It's necessary to have an impenetrable strategy and execution in a regulated environment.

Our candidates assist with planning, submissions, technical documentation, remediation and resolution management to help you meet regulatory requirements and deadlines.
-Provide Regulatory Expertise on International and Domestic submissions.

-Prepare documentation for regulatory registrations and submissions, including 510(k)s, PMA, NDA/INDA, ANDA as required.

-Provide Implementation support of electronic submission database for global submissions to meet requirements of EU e-CTD format.

-Prepare Standard Operating Procedures for post-market regulatory activities, to meet US, EU, Canada, Japan, China, Australia and many other country Regulatory requirements.

-Provide support in Regulatory Submissions, Strategy Development, Pre-Market Approvals/Post Market Approvals, CE Marking, Product Registrations etc.