During (early) drug development non-clinical studies (often also referred to as pre-clinical studies) are performed to assess the safety and efficacy of drug candidates. The objective of these studies is to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties for dosing strategies and toxicity (incl. geno-, repro-, and immunotoxicity) and toxicokinetics (TK).
Non-clinical study programs are designed in accordance with general regulatory guidelines. In addition, specific drug candidates or specific indications may require tailor-made study designs. The non-clinical study plan must be optimized to support each phase of clinical development, from first-in-man to late stage clinical studies and module 4 of the CTD of your MAA or NDA/BLA.
Progress-PME provides expertise and services in the field of non-clinical studies:
- Consultancy for PK/TK, safety pharmacology and toxicology studies
- GAP analyses and technical due diligences of third party non-clinical programs, e.g. for in-licensing opportunities
- Preparing non-clinical drug development plans
- Project management of (outsourced) non-clinical development programs
- Writing of non-clinical documents for regulatory submissions
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Meet one of our Senior Consultants, Luigi Jonk. Luigi has extensive experience in biological drug research and development. He provides scientific expertise and manages development and manufacturing activities in preparation for pre-clinical and clinical studies (Phase I-III). As a senior scientist, Luigi is experienced in efficiently executing a problem analysis, followed by planning and providing solutions. He enjoys working in a team and to get the best out of himself and the team members.
He has over 30 years’ experience in research and product development in Business and Academia.
Progress-PME is an independent project management and consultancy company with customers in life science. Primary in pharma, biotech and healthcare industries. For over 20 years Progress-PME provides support throughout the entire product life cycle. From process development to commercial production and at end-of-life decommissioning.
Our team consist of more than 50 professionals that includes engineers, project leaders, project managers, interim managers and consultants. With our team we share know-how in order to be able to help our customers throughout the complete process.