Protogenia Consulting Ltd
Protogenia Consulting Ltd offers non-clinical and early clinical development consultancy services, with more than 15 years' outsourcing and project management experience gained through virtual and mid-sized pharmaceutical companies. The services offered include: strategic planning to enable early clinical development and product registration; non-clinical and clinical project management; regulatory submission writing/review/sign-off (e.g. CTA/IND, MAA/NDA, IMPD and IB); and CRO selection and study management – clinical (up to Phase 2) and non-clinical (toxicology, safety pharmacology, ADME, bioanalysis). In addition, we have a broad network of contacts, for expert advice on IP, CMC, analytical services, regulatory affairs and quality assurance.