Regulatory Affairs

Covarrubias advises clients on the registration of food, drug, cosmetic, and medical device products, assisting them in adapting documentation and processes to comply with Chilean regulatory frameworks. The firm provides end-to-end regulatory support for companies entering the Chilean market, aligning scientific, legal, and business considerations to ensure efficient and compliant market access.

Legal services:

Preparation and submission of applications for health registration to local authorities. Health registration of pharmaceutical products and authorization of the entity before the health authority.
Regulatory Affairs for Pharmaceutical products and authorization of the entity before the health authority.
Regulatory Affairs for Medicines, Biological Products, Biotechnology Products, and Cosmetics.
Medical devices registrations.
Food and beverage regulatory law.
Regulatory Affairs for veterinary and agrochemical products.
Pharmaceutical and regulatory law.
Health summary proceedings before the health authority and representation before the courts, including administrative and judicial procedures.
Advice on clinical research projects and protection of clinical trials and research.
Pharmacovigilance advice and technical representation before the health authority.