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Pharma Regulatory Services in Peru - Overview
The pharmaceutical market in Peru is regulated by DIGEMID, which oversees the approval, importation, manufacturing, and commercialization of medicinal products. Companies must navigate detailed requirements for registering new drugs, generics, biologicals, and biotechnological products, each with specific dossier formats and quality, safety, and efficacy standards. Foreign manufacturers must appoint a local authorized representative, and compliance with GMP, stability requirements for climatic Zone IVb, and updated labeling norms can make market entry complex.
With strong expertise in LATAM markets, Freyr supports sponsors by preparing DIGEMID-compliant dossiers, managing submissions and queries, and ensuring timely approvals and lifecycle maintenance for all product types.
Pharma Regulatory Services in Peru
Freyr Expertise
Comprehensive Regulatory Strategy, Compilation & Submission Support for:
- New Pharmaceutical Product Applications
- Generic Product Registrations
- Biological & Biotechnological Product Registrations
- Sanitary Registration Renewals
- Post-Approval Variations and Amendments
- Good Manufacturing Practice (GMP) Dossier Preparation & Compliance Support
- Pharmacovigilance Compliance Support including submission of periodic safety reports
Technical and Strategic Regulatory Support
Regulatory Strategy Development
- Eligibility assessment for product classification (new, generic, biological, biotechnological, or natural products)
- Determination of dossier structure, stability study requirements for Peru’s climatic Zone IVb conditions, and labeling mandates
Dossier Compilation, Review & Submission
- Preparation of technical dossiers in DIGEMID-acceptable format for:
- Quality (CMC) sections
- Clinical & non-clinical summaries
- GMP and manufacturing documentation
- Risk management documentation
- Gap analysis of source data from R&D and manufacturing sites for Peruvian submission readiness
- Evaluation of product composition, specifications, COAs, excipient compliance, and packaging/labeling alignment with local norms
- Support for GMP certification applications, including document readiness, follow-up, and representation
Local Representation & In-Country Regulatory Support
- Acting as a Local Authorized Representative for foreign manufacturers
- Coordination with DIGEMID for submission tracking, deficiency responses, and query resolution
- Support with administrative procedures such as:
- Application fees and local submissions
- Label and artwork compliance
- Import permit-related documentation
Lifecycle Management & Ongoing Compliance
- Management of post-approval changes including:
- Minor and major variations
- Labeling updates
- Safety-related changes
- Compilation and submission of renewals before expiry to ensure uninterrupted market presence
- Submission of amendments and unsolicited information
- Support for pharmacovigilance obligations, including reporting of adverse events and submission of PSURs
Consultation During Development, Manufacturing & Commercialization
- Expert Regulatory guidance during formulation development, analytical testing, stability generation, and process validation phases
- Review of executed manufacturing and control documents for compliance readiness
- Evaluation of API and excipient information and alignment with DIGEMID expectations
- Continuous support during product scale-up, transfer, and commercialization phases
