Regulatory Affairs

KlinEra Regulatory team provides comprehensive support for our Sponsors/Clients to overcome the hurdles linked with the requirements of the DCGI, FDA, EMA and Other Regulatory Bodies.

We have a remarkable track record of getting on time approvals for clinical trials, from different regulatory jurisdiction. We help our Sponsors/Clients understand the requirement of respective Regulatory Authority and assist them appropriately to avoid any delay in approval.

We cater to our Sponsors/Clients in end to end process in a timely manner so that their product can go out in the market as scheduled.

Compilation of Regulatory Packages:

Preparing regulatory package for Regulatory Authorities. Coordinating and submitting Protocol or Protocol Amendments. Submitting interim and annual reports.

Communication with Regulatory Authority;

Communication and follow up with competent authorities including DCGI, FDA and EMA. Study and Investigator submissions to Ethics Committees and IRBs. Study Registration on respective registries, and other trial databases.

Import/Export Management:

Organization of any required import/export activities for IP and other study materials and samples. Management of regulated products. Procurement and import of difficult-to-find reference products.

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KlinEra Global Services

KlinEra provides innovative, customized clinical trial and research services.

Email Us

klinera@klinera.com

USA

311-313 Piercy Road San Jose,
CA 95138

P : (408) 365-3231
F : (408) 365-3232

INDIA

801, Neelkanth Corporate Park,
Vidhyavihar West, Mumbai 400086.

P : +91 22 2509 1470
F : +91 22 25004588