Regulatory Affairs Experts
for the Healthcare Industry.
Who are we?
COSMEPHARMA S.A. is a consulting firm specialized in comprehensive regulatory compliance advisory services for the pharmaceutical, food, cosmetic, household hygiene, medical devices, in vitro diagnostics, and veterinary products industries. We support our clients throughout the entire lifecycle of their products and commercial activities, from development to commercialization, ensuring efficiency, compliance, and quality. We work to help you meet regulations and optimize your processes.
Discover our main services:
Product Registration
We accelerate your market entry.
Regulatory Advisory
We help you avoid costly regulatory mistakes.
Strategic Consulting
We protect your investment and your reputation.
Licensing of Healthcare and Related Facilities
We assist you throughout the licensing process to ensure your facility meets the technical, regulatory, and legal requirements established by health authorities.
Why Choose Us?
- Experience: A multidisciplinary team with extensive background in general and health regulatory affairs.
- Commitment: Focused on efficiency and quality throughout all processes.
- Innovation: Adaptive and forward-thinking solutions in response to regulatory changes.
- Trust: Transparent relationships with clients, authorities, and stakeholders.
- Comprehensive Coverage: Services that span from development to post-commercialization.
- Personalized Advisory: Work plans tailored to each client’s specific needs.
Our History.
Founded in 2019, COSMEPHARMA was created with the vision of simplifying the complex regulatory landscape for companies that develop and market a wide range of products, including pharmaceuticals, nutritional supplements, herbal medicines, psychotropics and controlled substances; medical and dental devices, in vitro products, personal hygiene items, cosmetics and perfumes, food, tobacco-based products, psychoactive cannabis and hemp derivatives, veterinary products, sharps materials, personal protective equipment (Class I–IV), and household hygiene products (Risk I and II). Since our beginning, we have focused on building long-term relationships with our clients.
Strategic Advisory in Regulatory Compliance
Trust, Compliance, and Quality.
Industries and Service
Areas
Our services are designed to simplify complexity and support you with confidence at every stage.
We focus on facilitating regulatory compliance and streamlining the safe entry of your products into the market, ensuring quality, efficiency, and support throughout their entire lifecycle.
Food
• Establishment Registration – RE (importers, exporters, manufacturers).
• Advisory on Quality Control and Food Safety.
• Drafting of Quality Manuals (including the HACCP system – Hazard Analysis and Critical Control Points).
• Internal and Supplier Audits.
• Tailor-made development of processed food products (R&D&I).
Pharmaceutical Industry (Medicines, Supplements, and Herbal Products)
• Sanitary registration of new medicines (domestic and imported).
• Renewals and modifications of existing registrations.
• Advisory on Good Manufacturing Practices (GMP) and Good Storage Practices (GSP).
• Pharmacovigilance and management of adverse events.
• Ownership transfers and support throughout the product lifecycle.
• Company licensing before regulatory authorities.
• Management for obtaining GMP certificates (Good Manufacturing/Storage Practices).
• Preparation of dossiers and registration of new products to obtain Sanitary Registration from the National Directorate of Health Surveillance.
• Renewal, modification, or transfer of current Sanitary Registrations.
Personal Hygiene Products, Cosmetics, and Perfumes
• Licensing of manufacturing, importing, and distribution facilities.
• Sanitary registration and formula modifications.
• Sanitary certifications and labeling in compliance with regulations.
• Preparation of dossiers and registration of new products to obtain Sanitary Registration from the National Directorate of Health Surveillance.
• New sanitary registration and post-registration modifications (attestations).
Medical Devices
• Registration of new devices and modifications.
• Management of regulatory files and certifications.
• New Sanitary Registration and Post-Registration Modifications (attestations).
• Dossier and certification management.
• Management of Sanitary Registration Transfers.
Household and Sanitary Products (Domisanitary)
• Registration and licensing of domestic and sanitary products.
• Modifications of registrations and technical dossiers.
• Comprehensive management of regulatory files.
• New Sanitary Registration and Post-Registration Modifications (attestations).
• Dossier and certification management.
• Management of Sanitary Registration Transfers.
In Vitro Diagnostic Products
• Sanitary registration and required technical documentation.
• Advisory on labeling, storage, and usage conditions.
• New Sanitary Registration and Post-Registration Modifications (attestations).
• Dossier and certification management.
Veterinary Products
• Registration of pharmacological, supplement, and cosmetic veterinary products.
• Technical and regulatory advisory for veterinary companies.
• Compliance with specific regulations and sanitary certifications.
• Licensing of veterinary laboratories and facilities.
Psychotropic Products and Controlled Substances
• Submission and preparation of monthly forms to Dinavisa and Senad.
• Registration and re-registration with Dinavisa and Senad.
• Completion of the controlled substances logbook.
Comprehensive Consulting and Strategic Advisory
• Regulatory diagnosis and planning for new projects.
• Regulatory feasibility analysis of products.
• Support in regulatory audits and quality certifications.
• Document management and regulatory compliance planning.
• Preparation of documentation for participation in public tenders.
• Creation of manuals detailing hygiene and food safety procedures.
• Support for the growth process of micro, small and medium-sized enterprises (MIPYMES).
