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
Symbiorph Clinical Trialogy is the first CRO in India, which provide the sponsor full support from patenting their product to effectively propagating into the Indian market by acting as their associate channel partner for distribution of their novel drug and medical device in all therapeutic area.
We have already in phase of tying up with various hospitals specialized for Oncology, Cardiology, Endocrinology, Stem Cells and other therapeutic areas for effectively distribution.
