Regulatory strategy, RA partner, Regulatory Affairs consulting

Effective Regulatory strategy planning is an important aspect of any discovery program. The planning and designing of a scientifically robust non-clinical development plan tailored to the specific requirements of the project is of utmost importance in the successful filing of IND and further developments including the NDA submission. Our team of toxicologists, with several years of experience in the field of drug development, has supported numerous small and mid-sized pharma/biotech companies at various stages of drug development as a strategic partner. The non-clinical development programs and strategies proposed by our experts have been well accepted by various Agencies including the US FDA. The programs comprised of innovative small and large molecules including NDA submissions for new indications and alternate route of delivery.