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

Obtaining the permits, registrations, and authorizations needed to commercialize products in each market, plus renewal deadline alerts and support through the renewal.

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

Manufacturing and importing facilities must be registered or listed in the databases of the relevant health agency before their products can obtain a health registration. As part of the process, we manage these registrations.

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

Permits for local manufacturers whose products are made only for export.

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

Medical devices are subject to post-market surveillance. We prepare the required reports and follow them up.

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.

Marketing Authorization Holder (MAH)

When a foreign company cannot hold the registration, SPI acts as the holder in the countries that require it. We represent the client and answer to the relevant regulatory authorities.

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.