Services

Karidwen offers a wide range of services for the development of new chemical entities, biotherapeutics, and oligonucleotide therapies across a variety of therapeutic areas and indications, including oncology.

Services include (but are not limited to): 

• Design, implement, and oversee nonclinical safety studies from early discovery toxicity to chronic toxicity studies 

• Provide strategic nonclinical safety development plans, including investigating mechanisms of toxicities and their potential relevance to humans

• Develop timelines and budgets for nonclinical safety studies and integration with other functional lines

• Liaise with CROs for nonclinical safety studies including the generation of statements of work, contracts, and timelines 

• Conduct regulatory gap analysis assessments

• Perform both in-licensing and out-licensing due diligence reviews

• Compose and review documents as well as prepare packages for global regulatory submissions (pre-IND briefing packages, INDs/CTAs, NDAs/BLAs, Investigator’s Brochures, DSURs/PSURs, annual reports)

• Consult with health authorities on behalf of clients