BlueReg Group Development CMC Product Development CMC Product Development BlueReg can support with the Chemistry Manufacturing and Controls (CMC) development of a successful product whilst ensuring quality compliance. BlueReg services in this area include strategic consultancy during global pharmaceutical development and lifecycle management. BlueReg has a dedicated team of CMC consultants with significant expertise in all areas of CMC development. We have have expertise in all types of Active Pharmaceutical Ingredients (chemical, biological and herbals), drug product development, project management and decision making to drive investments. Our experts can advise you on pharmaceutical development strategy and provide oversight for the overall product development process to ensure key development milestones are successfully reached. From early development phases to registration, we ensure CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations. Our consulting services include the following: Strategic consultancy during global pharmaceutical development and lifecycle management Expertise in all types of Active Pharmaceutical Ingredient (API) (chemical, biological and herbals) Development of Active Substance Master File (ASMF), Drug Master File (DMF) and Certificate of Suitability (CEP) Development of USP / EP monographs Drug product development: Formulation (development and patentability), process (scale-up, validation and manufacturing strategy and Quality by Design (QbD)) Analytical development (development, validation and method transfer, gap analysis and specifications setting) Stability studies (design, trend analysis and setting of shelf life) Identification of contract manufacturing organizations (CMOs) and contract research organizations (CROs) and technology transfer Project management: coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies and transfer to CMO; registration and geographical roll out, including CMOs and CROs management Decision making to drive investments: due diligence, gap analysis and expert reviews Our experts Our team can also support you through the entire application process from development, to registration and post-approval management Isabelle Pinguet Sébastien Chargros Previous Associated services Drug Development Consulting & Strategy Currently developing a new medicinal product ? BlueReg can provide an end-to-end project plan to guide you from the development of your medicinal product right through to authorization and beyond. We can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers during the development process and beyond. Next Associated News EMA GUIDANCE – COVID-19 Given the support given to our clients in interactions with health authorities all around the... Learn more How antibody testing can help us fight COVID-19 ? There is a high demand around the need for antibody testing and the media frenzy... Learn more Nitrosamine impurities – are you ready to fulfil your legal obligations as a MAH by March 26th, 2020? During the summer 2018, authorities become aware of the presence of some nitrosamines in API... Learn more Contact our experts today Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management Make an enquiry About us Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success. Our links Affiliations Careers Terms of use Privacy Policy GDPR Get in touch with us here: contact@blue-reg.com Manage Cookies This site uses cookies and gives you control over what you want to activate OK, accept all Deny all cookies Personalize