Our services are aimed at the chemical-pharmaceutical business sector, i.e.
- The pharmaceutical industry
- The veterinary industry
- The cosmetic industry
- The phytotherapy industry
- The medical device industry
- The food industry
Advisory Services in Regulatory Affairs
- Overall Project Planning (veterinary or human drugs), in accordance with current regulations
- Regulatory strategy in product development
- Product Overview: Study of the market and possible patents
- Dealing with the Regulatory Agencies: Representation and dialogue with the regulatory authorities
- Submission of Registration dossiers (electronically): Application for marketing authorization from the regulatory authorities
- Updating the Registration Dossier: Variations of the conditions of authorization, Approvals, Renewals, Pharmacovigilance (postmarketing studies)
- Drafting of the Drug Master File of active ingredients: preparation and presentation thereof
- Expert Reports and tabular formats
- Training
- Scientific and technical audit:
- Of the Registration dossier: compliance at all times with current legislation
- Expert Reports and tabular formats
LOUFARM manages any transaction with the Regulatory Agencies (national, European or extra-community)
Customers
Team
- Personnel with a higher technical qualification and over 20 years’ experience in the pharmaceutical industry:
- Drug registration dossier management and development
- Implementation of quality systems (GMPs and ISO)