Grupo Profesional SERTERE – Regulatory Consulting in Venezuela
Pharmaceutical Registration
Pharmaceutical registration services in Venezuela. SERTERE ensures compliance with INHRR and MPPS requirements for safe and efficient approvals.
40+ years of experience
Experts in Venezuelan regulatory processes
Complete dossier and labeling support
Pharmaceutical Registration in Venezuela
Grupo Profesional SERTERE provides specialized support for pharmaceutical product registration in Venezuela, ensuring compliance with strict regulatory standards.
Regulatory Authorities
- Ministry of Health (MPPS)
- INHRR
Key Requirements
- Sanitary registration
- CTD dossier
- GMP certification
- Stability studies
- API and quality documentation
- Bioequivalence (if required)
- Spanish labeling and leaflet
Local Testing Requirements in Venezuela
- Samples may need to be submitted for local laboratory analysis
- Requirements depend on product type and regulatory evaluation
Local testing may be required, particularly for:
- Quality control verification by INHRR
- Bioequivalence studies (in some cases)