BlueReg is a consultancy organization offering strategic regulatory advice and hands-on outsourcing solutions to life sciences companies through the entire lifecycle of their products.
Leveraging the broad expertise of our internal consultants and network of international qualified partners in the field of regulatory affairs and pharmacovigilance, we provide flexible solutions or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.
CMC Product development
Product development : Supporting the development of the best product while ensuring quality compliance
- Strategic consultancy during global pharmaceutical development and lifecycle management
- Expertise in all types of API (chemical, biological, peptides, herbals) – Development of ASMF, DMF, CEP – Development of USP/EP monographs
- Advice on Drug product development and review of scientific documentation :
- Formulation (development, patentability), process (scale-up, validation, manufacturing strategy)
- Analytical development (development, validations and transfer, gap analysis, specifications)
- Stability studies (design, trend analysis, setting of shelf life)
- Project management : coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies, transfer to CMO, to registration and geographical roll out, including CMOs and CROs management
- Decision making to drive investments: Due diligence, gap analysis and experts reviews
CMC Regulatory support
CMC Regulatory support : Interacting with authorities at every stage of development and generating associated
- CMC regulatory strategy : Identify the scientific package needed at each development stage, check the consistency between available data & regulatory requirements, perform CMC gap analysis
- Interaction with Health Authorities (EU/US/Export)
- Geographical roll out
- CMC variations
- Scientific writing of regulatory documents : ASMF, DMF, CEP, IND, IMPD, MAA and NDA / BLA module 3, writing of responses to agency questions.
BlueReg, a full range of services
|Drug Development Consulting||Drug Registration||Lifecycle management|
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