Pharmaceutical Development Consultancy
Protogenia Consulting Ltd offers pre-clinical and clinical development consultancy services to the pharmaceutical, biotech and cosmetic industries. With over 30 years industrial experience and over 25 years project management and outsourcing experience gained through virtual, mid-sized and large pharma, the services we offer include:
- Strategic planning to enable clinical development and marketing of small molecules, peptides, biologics and advanced therapy products
- Programme management for non-clinical/clinical development up to Phase 3
- Regulatory support (generation and review of Investigator Brochures, IND/CTA submissions, Scientific Advice requests, Paediatric Investigational Plans)
- CRO selection, contract negotiation, study design and monitoring of pharmacology, ADME and GLP compliant toxicology studies
- Toxicology risk assessments for the cosmetics industry
- Assistance in developing Quality Management Systems (SOPs) to support regulatory and clinical development activities
- Project Management of Grant Award funded R&D projects (MRC, Wellcome Trust)
In addition, we have a broad network of Drug Development contacts, and can provide expert advice on:
- Chemistry Process Development and Manufacture (API)
- Pharmaceutical Development and Manufacture (Drug Product, IMP)
- Regulatory Affairs
- Quality Assurance
- Analytical Services