Services provided
Sanitary Registration and Regulatory Representation in Peru
We provide comprehensive regulatory affairs solutions to support the entry and commercialization of pharmaceutical products, medical devices, and health products in the Peruvian market.
We manage the Sanitary Registration process before the General Directorate of Medicines, Supplies and Drugs (DIGEMID), ensuring full technical, regulatory, and documentary compliance with current Peruvian legislation.
Scope of Services
- Preliminary regulatory feasibility assessment.
- Preparation and submission of technical dossiers.
- Follow-up and management of regulatory observations.
- Variations, extensions, and renewals of registrations.
- Updating of technical documentation (package inserts, labeling, technical sheets)
- Custody and regulatory management of dossiers.
Holder Service in Peru
We act as the Marketing Authorization Holder (MAH) for foreign companies without a local presence, assuming regulatory representation before DIGEMID under strict compliance standards.
Our capabilities include:
- Valid Drug Distribution License (Droguería License).
- Warehouse certified in Good Storage Practices (GSP / BPA).
- Licensed Pharmaceutical Chemist as Technical Director.
- Regulatory administrative infrastructure.
Our approach is based on confidentiality, regulatory compliance, and operational continuity, ensuring solid and reliable representation in the Peruvian market.
