Our Regulatory Affairs Team offers seamless expert regulatory advice on pharmaceuticals, biotech and medical devices. The most optimal approach to be taken is determined only after an in-depth understanding of the project, strategic review of the applicable regulatory requirements, timeline planning and stringent execution of regulatory filings, agency contacts and regulation compliance. Experts from other departments also assist the Regulatory Affairs Team, thus forming a complete Clinical Development Group,in order to ensure successful product registration.
The Regulatory Team has the required skill-set in preparing and compiling dossiers, and submitting clinical trial applications.
Our team is trained to work closely with the sponsor’s project team, to provide Regulatory Services and to work as an authorized communications agent for the Sponsor.
Our team has experts who are well-versed in the discipline. They are subject matter experts who are with the capability to offer support in all the phases of clinical Drug Development – right from the creation of a new IND or IDE to post-marketing support, maintenance and compliance.