Regulatory Affairs:

Caplin is self-reliant on making end-to-end regulatory submissions for generic products in US. Appropriate regulatory advice is obtained from Agency through controlled correspondence for developing complex generic products. A robust review mechanism is in place to avoid any Refuse to Receive (RTR) situation. Product dossiers are compiled in-house in to eCTD modules using eCTD/eSPL software. Submissions are made to the Agency using Caplin’s Electronic Submission Gateway (ESG).

Received acceptance from Agency for Competitive Generic Therapies (CGT) and Priority Review assigned for few ANDA applications.

Intellectual Property Rights:

• Our Intellectual Property Rights team interdisciplinary approach is tailored to suit organizational business and strategic objectives. Our Intellectual Property Rights team foresee the product filing timelines by starting with the assessment of patent landscape, continuing through strategy and litigation as an end-to-end process to support the organizations business objectives.

• Our Intellectual Property Rights team closely track the competitive landscape and dynamic global pharmaceutical marketplace for each and every product, identify and further pursue market opportunities without delay to meet organizational objectives and bringing the generic product in to the market to meet healthcare demands.

• Our Intellectual Property Rights team is distinguished by a high degree of technical and scientific expertise in understanding Hatch-Waxman Litigation and providing consistent inputs to support organizational business objectives.

• Our Intellectual Property Rights team effectively and strategically work with the R&D team in creating IP assets to the organization.