The drug development process can be a long and costly process. Selecting and developing the most appropriate drug candidate is paramount to successfully achieving a timely marketing authorisation. The provision of timely, sound regulatory strategy non-clinical advice ensures that your drug candidate can support your clinical development programme from the initial FIH (first in hand) trials through to commercial approval and beyond as required.
The NDA Team of pharmacologists / toxicologists have indepth experience in establishing non-clinical programmes to meet the regulatory needs for the development of new chemical entities, biologics, biosimilars, and advanced therapeutic medicinal products. Their expertise is gained from more than 20-years within industry and the global regulatory arena, and across many therapeutic classes of drugs. This gives you access to key insights into the most efficient and appropriate regulatory strategy to progressing your drug candidates through to commercialisation.
Our track record
NDA has been supporting a wide range of start-up biopharma, and small and medium size pharmaceutical companies in their drug candidate selection through our carefully considered gap analysis process. In so doing NDA has provided them with the necessary guidance and regulatory support to successfully progress their FIH clinical trials, and then on through subsequent development and commercialisation of both adult and where required paediatric therapeutic indications.
How we help
NDA have the technical knowledge across a wide range of therapeutic indications and various routes of administration (including oral, parenteral, inhalation, dermal, ocular and intraocular), to support the progression of a drug candidate from lead optimisation through achieving first in human clinical trials, subsequent marketing authorisation and post-approval follow-up measures including paediatric approvals.