Drug project toxicology
All our consultants have many years’ experience of providing toxicologic proficiency and support to drug projects within most disease areas, be it for small molecules, peptides or antibodies. We provide expertise which is vital for progressing a project to the next stages of development. Our clients range from small academic Life Science groups to Big Pharma companies.
Our services encompass a variety of alternatives, from short-term problem-solving activities to long-term project engagement.
Examples of services:
- Full project responsibility for the toxicology and safety pharmacology disciplines, functioning as an integrated member of the client’s project group.
- Compilation of the nonclinical safety parts of regulatory documents (including integrated risk assessment) prior to clinical trials, as well as periodic updates of: IB, BD, CTA, IMPD, IND, AR/DSUR, NDA.
- Participation in interactions with authorities (EMA, FDA or individual country’s regulatory bodies).
- Risk assessment of drug targets.
- Literature- and database-derived compilations concerning a specific toxicology query.
- Toxicology support within life cycle management.
- Toxicology support regarding in- and outlicensing (Due Diligence)
- Planning of nonclinical safety packages to support diverse clinical development programs, in accordance with current regulatory guidelines (ICH, EMA, FDA).
- Planning, outsourcing, monitoring and critical review of nonclinical in vitro and in vivo safety studies (GLP and non-GLP).
- Study design.
- Evaluation of study results.
- Risk assessment of, and strategies for, qualification of excipients (new, or for new administration route)
Risk assessment of, and strategies for, qualification of impurities during manufacture and in final drug substance (API) and drug product (see also “Impurities”).
Contact us if you think we can help your project and we will gladly arrange a meeting to discuss if, and how, we can be of assistance. Cost-free and no obligations.