01
Regulatory
Affairs
We are a company with over 15 years of experience providing support and advisory services to businesses for the registration, re-registration, modifications, and/or updates of their Pharmaceutical Products, Medical Devices, and Sanitary Products. Our extensive knowledge of the regulatory sector gives companies the confidence to entrust us with their regulatory processes, allowing them to dedicate their time to commercial, financial, or other operational priorities. Regulatory affairs are critically important because this department ensures products meet the three fundamental pillars: QUALITY, SAFETY, AND EFFICACY.
Regulatory Affairs >
- Registration of pharmaceutical products, medical devices, and sanitary products.
- Re-registration of pharmaceutical products, medical devices, and sanitary products.
- Modifications (updates) of pharmaceutical products, medical devices, and sanitary products.
- Registration of biological products (biotechnological-biosimilars).
- Re-registration of biological products (biotechnological-biosimilars).
- Modifications (updates) of biological products (biotechnological-biosimilars).
- Regulatory intelligence: We conduct feasibility studies according to the regulatory framework to help companies make assertive decisions for successful sanitary registration. We also provide pre-registration, registration, and post-registration strategies to ensure continuous compliance, avoiding risks, obsolescence, or penalties over time.
- We provide alternatives and solutions when the regulatory authority-DIGEMID publishes regulatory updates, ensuring uninterrupted commercialization of pharmaceutical products, medical devices, or sanitary products.
Dirección: Calle José Toribio polo 260, oficina 201, Miraflores. Lima, Peru.
