A team of experienced and qualified professionals with up-to-date regulatory awareness ensures a strong support to the formulation development team and also our real-time response to any change in the regulatory environment, assuring regular dossier updates.
Our Regulatory Affair team works closely with the formulation development and quality assurance teams to execute projects successfully. It engages itself from the very beginning of the project with various licenses and review of development and vendor documents. Furthermore it considers all scientific disciplines and constantly changing regulatory requirements to develop the Regulatory Strategy for a successful registration.
Our team is capable of writing and compiling dossiers in all formats like eCTD, ACTD, ANDA or Country specific formats. Our team is also well experienced in all different types of submission procedures which is either DCP, MRP or National route. Our team assures a structured follow-up of registrations covering EMA, as well FDA regulatory compliance. Other activities like comprehensive documentation, archiving of documents etc. are also done meticulously because we aspire to offer a complete end-to-end solution to our partners.
Our expertise is in developing niche or complex products which require interaction with regulatory authorities on a regular basis on varied subjects like bio-equivalence, reference products, methods etc. Consequently we have developed a better understanding on the requirements.