The pharmaceutical and medical device industries are highly regulated. Our experienced regulatory affairs experts will make sure that our clients regulatory documents will comply with all of the regional regulations and laws pertaining to their business.

Our Regulatory team supports your product both in the provision of applications and reports to the different regulating bodies, and the submission of clinical site Essential Documents on behalf of the sponsor. We offer regulatory services for both pharmaceuticals and medical devices industry. We work with you to plan, prepare and complete all of your regulatory submissions and then act as your liaison in all interactions with regulatory agencies.

Regulatory affairs services include but not limited to:

Preparing and filing clinical trial applications (CTA) to regulatory authority
Helps in preparing, filing and getting approval for amendment in protocol, investigator brochure, Inform consent form etc
Coordinating interactions with regulatory authority as authorized agent
Help in deciding local patient insurance
Help in getting IEC/IRB approval
Advice on Labeling
Reporting Serious Adverse Event to applicable regulatory authority within strict time frame
Obtaining import/ export licenses for investigational products, biological samples and medical devices
Pharmacovigilance and Periodic Safety Update Reports (PSURs)
Annual reports & safety updates