Regulatory Affairs

Experts in providing consulting services to ensure the legal and technical compliance of our clients' products within the Latin American market.

Our extensive experience has allowed us to work with companies across all sectors that fall under the scope of regulated goods, always committed to promoting legality, transparency, and best practices. We have a multidisciplinary team of experts dedicated to offering our clients the best and most timely assistance possible.

Our team specializes in offering the following services:

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.

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.

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
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)

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. 

Specialized Advisory

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

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.

Facility Registration

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

Label Compliance

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

Compliance Certificates

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

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

Regulatory Due Diligence

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

Toxicology Reports

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

 

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.

Products We Serve:

Products

Food and Beverages

Natural or artificial products for human consumption, including:

  • Non-alcoholic beverages
  • Foods
  • Alcoholic beverages with varying alcohol content
  • Energy drinks
  • Sports hydration beverages
  • Fresh, tinned or processed fish and seafood products
Cosmetics

Products applied locally to superficial parts of the body to clean, perfume, alter, and/or maintain their condition.

Domestic Hygiene Products

Products designed to clean, disinfect, and deodorize spaces and everyday household objects. This category excludes products with similar functions intended for industrial use.

Personal Hygiene Absorbents

Products such as disposable diapers, sanitary pads, tampons, and panty liners.

Domestic and Public Health Pesticides

Products used to prevent and control any organism considered a pest, as defined by the relevant health authority.

Medical Devices

Medical Devices and Biomedical Equipment

Products for prevention, diagnosis, and treatment of medical conditions without pharmacological, immunological, or metabolic actions.

In-Vitro Diagnostic Reagents

Reagents used to analyze human samples for detecting pathogens, metabolites, or substances.

 

Medications and Biological Products

Synthetic Pharmaceutical Products

Products with synthetic components, available in various pharmaceutical forms.

Biological Pharmaceutical Products

Products derived from organisms, living cells, or their parts, obtained through methods such as cell culture, microorganisms, viruses, recombinant DNA, and more.

Homeopathic, Herbal and Dietary Suplements

Homeopathic Medications

Pharmaceutical products created using homeopathic techniques.

Herbal Products

Medicinal products with active substances derived from plants.

Dietary Supplements

Products that supplement or complement the normal diet of humans and/or animals.

Veterinary Products

Products for Animal Use

Includes food, synthetic medications, biological medications, herbal medications, disinfectants, homeopathic products, and cosmetics for animals.

Agricultural Products

Includes raw materials, ingredients, pesticides, fertilizers, and bio-inputs.

Let's work together to turn opportunities into reality.

Key People

Ana De la Ossa

Coordinator of the Regulatory Affairs Department

adelaossa@spiamericas.com

Isabel Sanín

Director of the Regulatory Affairs Department

Regulatory Affairs Team

Isabel Sanín, Ana de la Ossa, Sandra Preciado, Mauricio Cortés, Juan José Barragán,  Catalina Ospina Heidy Díaz,  Alejandra Cristancho,  Magali Trujillo

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