A successful nonclinical strategy and program requires addressing challenges and using opportunities.
Our nonclinical team has the experience and expertise to support our clients in all stages in nonclinical development and the regulatory approval process, be it for originators, generics, small molecules, biologicals, biosimilars, nanomedicines, medical devices and combination products.
Our support may include:
Creating a customized nonclinical pharmacology, pharmacokinetics and toxicology strategy and program to maximize the likelihood of moving drug candidates into the clinic (CTA/IND) and onto the market (MAA/BLA/NDA).
Selection and management of appropriate contract research organizations (CROs), monitoring and reporting of nonclinical studies
Due diligence and gap assessment of nonclinical programs
Authoring nonclinical sections in regulatory documents (IB, Briefing Book, CTD)
Support interactions with Regulatory Authorities for Scientific Advice, Formal FDA Meetings etc.
Safety/risk assessments in the context of CTD module 2.4 submissions, IMPD/IND’s and for specific issues in e.g. genotoxicity.
Drafting rationales for not performing certain nonclinical studies
Answering EMA or FDA comments following e.g. CTD submissions
Biological evaluation of medical devices including risk assessment
Would you like to have our support in your nonclinical strategy and program? Please contact us throughContact form.