Our Pharmaceutical and Cosmetic Regulatory Affairs Services
Galiéneo Consulting supports pharmaceutical, biotech, food supplement and cosmetic companies at every stage of their regulatory dossier lifecycle. Our team of pharmacists, PhDs in biology and chemical engineers operates across France, Europe and the North African market, with strong expertise in CMC, eCTD and electronic publishing, in line with EMA, ANSM and MENA authorities’ requirements (including ANMPS in Tunisia).
Whether you are a pharmaceutical laboratory, a biotech company, a contract manufacturer or a cosmetic brand, we provide hands-on, responsive and tailored regulatory expertise to secure your timelines, ensure dossier compliance, and prevent any risk of stock-out or market withdrawal.
Research and Development
We work alongside qualified partners on the analytical, pharmaceutical development (galenics) and chemistry aspects of your projects from initial formulation through to the quality dossier.
Regulatory Consulting
Our team provides end-to-end regulatory support throughout the lifecycle of your Marketing Authorizations (MA):
– Life-cycle management of MA dossiers
– Regulatory support for marketing authorization holders
– Primary point of contact for CMOs, suppliers, clients and internal departments
– Development and validation of CMC strategy
– Change management in coordination with Quality and Production departments
– Critical review of development reports
– Regulatory intelligence and interactions with health authorities
Regulatory Writing and Dossier Submission (CTD / eCTD)
We prepare and submit your regulatory dossiers in compliance with European and international standards:
– Preparation of quality modules (Module 3 and 2.3) for Marketing Authorization
– Drafting and updating of CMC sections for registration, renewal and variations
– Responses to health authority questions on CMC sections
– Conversion from NtA to CTD format
– Preparation and submission of variations (types IA, IAIN, IB, II)
– eCTD formatting and publishing using recognized publishing software
– Electronic submission to European authorities (national, MRP, DCP, centralized procedures) and international authorities, including under Tunisia’s ANMPS eCTD mandate
Herbal Medicinal Products
Preparation of the quality section of registration dossiers for herbal medicinal products, in line with the specific requirements for this category.
Pharmaceutical Dossier Audit
Audit and gap analysis of the quality section of your MA dossiers, to anticipate authority questions and secure your regulatory deadlines.
Cosmetic Products
Safety assessment (CPSR), Product Information File (PIF) compilation, and compliance with Regulation (EC) No 1223/2009, with regulatory support for market entry in Europe and North Africa.
Food Supplements
Regulatory advice and support for the market launch of your food supplements, in accordance with applicable regulations.
Why Galiéneo Consulting?
Founded in 2017 by Amel Amara, PharmD, Galiéneo Consulting combines strong scientific expertise with close, hands-on client support for pharmaceutical laboratories, biotechs, contract manufacturers and cosmetic brands. We are pioneers in the North African market, with particular expertise in the Tunisian and Algerian regulatory landscape through our subsidiary Galiéneo Life Sciences Advisors (GLSA).
Contact us: https://www.galieneo-consulting.com/en/contact/ to discuss your regulatory project.