Regulatory Affairs

Product classification

As part of our process, we evaluate products to determine their category or group based on the regulations of the health authority responsible for registration. This ensures products are appropriately positioned within the relevant regulatory framework, providing clients with the most efficient alternatives in terms of procedures and costs.

Registrations, renewals, and notifications

Our team assists clients in obtaining the permits, registrations, and authorizations needed for their products' commercialization. We also notify clients of renewal deadlines and provide support throughout the renewal process.

Registration modifications

Any changes to a product or its manufacturing process must be reported to the Health Authority. We actively support clients in this process, ensuring compliance, regulatory efficiency, and the proper steps for product commercialization.

Facility registration

For food products, we assist in registering manufacturing facilities as required by regulatory entities.

NOC (non-obligatory certification)

For products not requiring health registration, we offer evaluations to determine their eligibility and guide clients through the certification process.

Certificate for export

Our team is highly qualified in assisting local manufacturers in securing permits for exporting their products.

Free sale certificate

Supporting the process of obtaining certificates for domestically produced goods intended for export.

Controlled substance certificates

We assist clients whose products contain controlled substances requiring a specific certificate for commercialization.

Compliance certificates

We support obtaining certificates that confirm compliance, such as sodium content certification for food products.

Health authority authorizations

We advise clients on obtaining health authority documents for specific procedures, including:

• Advertising
• Product and label exhaustion
• Food additives
• Promotional incentives
• Non-available vital products

Specialized advisory

For products with ingredients, claims, or uses requiring specialized review, we offer consulting services to prepare applications for consideration by regulatory authorities.

Technical-legal opinions

We provide tailored technical and legal opinions based on applicable regulations and our extensive experience.

Toxicology reports

We assist in obtaining toxicity reports and classifications for pesticide products.

Certification support

We provide comprehensive support in obtaining product-specific certifications that ensure their commercial viability. We participate in every stage of the process, increasing the likelihood of success. Certifications include:

• Sanitary conditions
• Sanitary and technical decision
• Production capacity
• Certificate for capacity of storage and conditioning
• GMP (Good Manufacturing Practices)
• HACCP (Hazard Analysis and Critical Control Points)

Label compliance

We review labels for regulatory compliance and create models for nutritional labeling, including nutritional tables, warning seals, and applicable claims.

Device and reagent coding (UDI-DI)

We help medical device and IVDR manufacturers to prepare and submit necessary data for compliance with UDI-DI standards.

Post-market surveillance

Assistance in creating and managing post-commercialization surveillance reports for medical devices.

Pharmacovigilance

Support for pharmaceutical product surveillance, generating required reports for health authorities.

Regulatory assistance at ports of entry

We handle regulatory matters during product importation, ensuring compliance for market entry.

Sanction proceedings

We advise clients under regulatory sanctions, designing strategies to ensure due process and favorable outcomes.

Regulatory due diligence

We assess the regulatory status of a client's product portfolio and develop strategies for commercial viability.

Regulatory hosting services

For foreign companies unable to hold registrations, we offer hosting services, acting as their representative for regulatory purposes in the required countries.

Translations and legalizations

We translate technical and legal documents for regulatory processes, offering both simple and official translations as needed.

Specialized consulting

We tailor regulatory strategies and provide specific solutions to meet our clients' needs.