During drug development nonclinical studies are essential to provide a treatment rationale, identify efficacious dose levels and potential safety concerns. Furthermore, nonclinical data paves the way for conduction of first-in-human studies and supports later stage clinical development up to drug marketing approval.
We can support you in all aspects of nonclinical development and regulatory interaction strategies. From the designing of nonclinical programmes to support your drug screening, lead identification, IND-/CTA-filings through to nonclinical studies required to support conduction of your Phase 2 and 3 studies, as well as marketing authorisation applications worldwide.
We also offer you services in nonclinical outsourcing, namely CRO selection, study oversight, study design and study protocol generation, report writing and review, CRO monitoring and steering for your whole nonclinical development. In addition, we provide you with support of your clinical first-in-human study designs and PK/PD/ADA assay development and validation.
We also conduct gap analysis of nonclinical data, clinical PK/PD/ADA results, target liability assessments, risk assessments and support you with the preparation or review of nonclinical documents in support of all regulatory activities.
We support you with:
- Designing of nonclinical strategy throughout all drug development stages for NCEs, NBEs, biosimilars, vaccines as well as ATMPs
- Nonclinical regulatory support of health agency interactions (scientific advice, preIND meetings, ODAs, PIPs, CTA/IND/MAA/NDA/BLA filings)
- Outsourcing/project management of pharmacology, safety pharmacology, ADME/pharmacokinetics, toxicology studies
- Due diligences, gap analysis, risk assessments, PDE/OEL assessments
- Interactions with collaboration and investment partners
- Preparation of IB; nonclinical CTD modules for CTA, IND, MAA, NDA, BLA submissions
- Support in the translation from non-clinical to first-in-human study designs
- Support of bioanalytical method development/validation for non-clinical studies and human clinical trials (PK, PD, biomarkers, and ADA/nADA assays)
- Preparation of immunogenicity assessments
- Preparation of environmental risk assessments
