H2 Pharma offers specific technical guidance and management of preclinical development programmes.
Our services are centred principally on preclinical testing management (both in vitro and in vivo), API characterisation and early formulation screening and selection.
We employ our extensive early formulation development expertise to enable the rapid design and selection of formulations for preclinical studies. We also assist Clients in establishing (non-commercial) enabling oral and parenteral formulations for rapid progression to First-In-Human studies.
We work with the Client’s internal or external laboratory resources to plan and manage the following activities:
- Pre-formulation and biopharmaceutics evaluation of APIs
- Drug delivery assessment and pre-clinical testing in animals
- Development of toxiological and preclinical formulations
- Preparation of enabling formulations for rapid first-in-man studies
- Sourcing and management of external laboratory providers