R & D
MEDICON views Research and Development as a vital component of business strategy that will provide us with an competitive advantage. We recognize that ‘innovation is the key to success’ and have been consistently investing in R&D over the last decade.
Our team is provided with an environment that nurtures excellence and innovation which is most essential to develop complex and challenging first-time combination products and also first-to-launch generic products in our focus therapeutic segments. The R&D team is completely involved in all projects from concept to Phase IV study tracking market acceptability and after-launch status.
Adoption of latest technology and constant up-gradation of knowledge base are keys to our novel product development, which is supported by a detailed study and assessment of gap in medical needs on continuous basis.
This is reflected in our preparation for both domestic and international markets where we market our products. We have multiple ANDAs awaiting approval from USFDA and significant numbers of product registrations are pending for approval in emerging markets at different stages from respective health authorities.
Our Drug Regulatory Affairs (DRA) team is involved in product registrations for various markets (domestic, emerging and regulated) across continents. Core responsibility of our DRA team is to register products in international and domestic market to gain entry in the shortest possible time. The team comprising of highly qualified pharmacists is focused on understanding the prerequisites and new developments in Food and Drug Administration (FDA) guidelines for product registrations across the globe. Continuous training is imparted to the team to be abreast with constant updates on the requirements of the various regulatory authorities.
Our R & D Department is dedicated towards development of New Dosage form for the present Generic molecules which would enhance its Pharmacokinetic profile and Bioavailability.
Stability & B.A/B.E Study:
Protocols for Stability Studies and Bio-Availability Studies / Bio-Equivalence Studies are designed and the said studies are done with tie ups.
Analytical Method Development / Validation:
In process and finished products analytical methods and quality control methods are developed and validated.
Process Development / Validation:
Manufacturing process including various stages of the drug manufacturing with in process quality control checks are developed and validated. And the same is scaled up from pilot batch to scale up batch size after validation studies.