Strategic Regulatory Partner for Success in Peru

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Pharma Wizard Peru

Promising economic outlook coupled with government’s willingness / commitment to investments in healthcare sector makes Peruvian market offer lucrative business opportunities for medicines and medical devices manufacturers. The pharmaceutical and medical device market in Peru is regulated by Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). Considering the regulator’s newly published amendments to regulatory requirements, foreign manufacturers who are willing to enter the region might face the challenge of managing hidden procedures.

Pharma Wizard, as a specialized global Regulatory partner and with proven Regulatory Affairs and QA experience, assists manufacturers to navigate through the Peruvian Regulatory guidelines and streamline necessary document preparation and submission activities for timely registrations and approvals. Pharma Wizard is capable to provide Regulatory consulting services in Peru for:

Industries We Serve in Peru

Food Supplements Regulatory Support in Peru

The Regulatory framework for foods and dietary supplements has been developed by the Peruvian Ministry of Health (MoH) which includes registration and labeling requirements, claims, and marketing authorizations. The authorized body responsible for granting marketing authorizations is the General Directorate of Medicines, Supplies, and Drugs (DIGEMID).

Medical Devices Registration

Medical devices are classified into four risk classes (I–IV), with higher-risk devices requiring more comprehensive documentation. Registration is mandatory for all classes, and foreign manufacturers must appoint a local legal representative. Approval time ranges from 3–9 months.

Pharmaceutical Drug Products Prescription & OTC Registration

All pharmaceutical products, including prescription and OTC drugs, must be registered before marketing. The process involves submitting administrative, quality, and (where needed) clinical documentation. Approval typically takes 6–12 months, and the registration is valid for 5 years.

Pharma Wizard Offerings

Strategic Regulatory Consulting
Regulatory roadmap for market access
Regulatory Affairs & Regulatory Intelligence
Registration pathways and license management services
Dossier Gap Analysis, preparation, review and management
Intelligence reports

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Company Profile

Portfolio

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Food & Food Supplements Product Services

Categories Supported

Sustainability Services