Grupo Profesional SERTERE – Regulatory Consulting in Venezuela
We help companies successfully navigate Venezuelan health authority requirements
Grupo Profesional SERTERE is a trusted regulatory consulting company in Caracas, Venezuela, specializing in product registration and compliance for national and imported products.
Ensuring fast, accurate, and compliant product approvals
40+ years of experience
Experts in Venezuelan regulatory processes
Complete dossier and labeling support
About Us
Regulatory Experts in Venezuela
Years of experience
Customers
Products
Grupo Profesional SERTERE is a family-owned regulatory consulting firm in Caracas with nearly 40 years of experience in Venezuela’s regulatory environment.
We specialize exclusively in product registration and regulatory compliance, supporting companies that want to enter or maintain their products in the Venezuelan market.
Our expertise focuses on:
- Preparing and reviewing complete regulatory dossiers
- Ensuring compliance with local health authorities and regulations
- Supporting labeling adaptation and regulatory updates
We do not provide research and development (R&D) services. Instead, we focus entirely on making sure your product meets all legal, technical, and administrative requirements in Venezuela, reducing delays and increasing approval success.
Cosmetics Registration in Venezuela
Our Services Include:
- Complete dossier preparation and review
- Verification of ingredient compliance with Venezuelan regulations
- Labeling adaptation to local requirements
- Support with sanitary notification or registration submission
- Guidance on corrections or updates requested by authorities
Medical Device Registration in Venezuela
Our Services Include:
- Classification of medical devices according to Venezuelan regulations
- Preparation and completion of technical dossiers
- Review of international certificates for local acceptance
- Labeling and IFU compliance verification
- Support during submission and authority review process
- Assistance with post-registration updates or variations
Pharmaceutical Registration in Venezuela
Our Services Include:
- Full dossier review and gap analysis
- Adaptation of international dossiers to Venezuelan requirements
- Verification of compliance with INHRR standards
- Labeling and packaging compliance support
- Assistance with authority queries and required modifications
- Support for renewals and variations
Food Supplements (Dietary Supplements) Registration
Our Services Include:
- Review of ingredients against Venezuelan permitted lists
- Dossier preparation and submission support
- Labeling compliance and claims verification
- Support with authority observations and corrections
- Guidance on reformulation if required for compliance
Food Product Registration in Venezuela
Our Services Include:
- Complete dossier preparation and verification
- Compliance review with COVENIN and sanitary standards
- Labeling adaptation to Venezuelan regulations
- Support during submission and approval process
- Assistance with product updates, renewals, and modifications
What We Do
End-to-End Regulatory Support
Dossier Preparation & Completion
We ensure all documentation meets Venezuelan regulatory standards.
Labeling Compliance & Adaptation
We help adapt labels to meet Venezuelan legal requirements.
Regulatory Submission Guidance
We support the submission process with local authorities.
Dossier Updates & Variations
We assist with any changes required during or after registration.
What Makes Registration in Venezuela Complex
Contact us
Benefiting from over 40 years experience.
Everything is in Spanish
National Authorities are not digitalized. There is no online portal.
Changing regulatory requirements
Strict documentation and formatting rules
Spanish labeling and technical compliance
Potential need for local testing
Communication with multiple authorities
Long review timelines without proper follow-up
Why Choose Grupo Profesional SERTERE
Complete End-to-End Regulatory Support
Highly Specialized Expertise
- 40+ years of regulatory experience in Venezuela
- Company with address as oppose to freelancers
- Deep understanding of local authority expectations
- Focus exclusively on registration
- Proven ability to reduce delays and avoid rejections
- Connections and Networking build after years in the market
Supports all registration Steps:
- Product classification and regulatory strategy
- Full dossier preparation and technical review
- Tranlation of dossier if necessary
- Correction of documentation gaps
- Adaptation of international dossiers to Venezuelan requirements
- Labeling compliance according to local laws
- Submission to health authorities (MPPS, SACS, INHRR)
- Continuous follow-up with authorities
- Response to regulatory questions and deficiencies
- Support with local testing requirements when applicable
- Management of dossier updates, variations, and renewals
Tangible Benefits for Your Company
- Faster and more predictable approvals
- Reduced risk of rejection or delays
- Fully compliant dossiers from the start
- Clear understanding of Venezuelan requirements
- Efficient communication with authorities
- Support for both imported and locally manufactured products
- Long-term regulatory partner in Venezuela