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:
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.
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.
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.
For products not requiring health registration, we offer evaluations to determine their eligibility and guide clients through the certification process.
Our team is highly qualified in assisting local manufacturers in securing permits for exporting their products.
Supporting the process of obtaining certificates for domestically produced goods intended for export.
We assist clients whose products contain controlled substances requiring a specific certificate for commercialization.
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
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)
We help medical device and IVDR manufacturers to prepare and submit necessary data for compliance with UDI-DI standards.
For products with ingredients, claims, or uses requiring specialized review, we offer consulting services to prepare applications for consideration by regulatory authorities.
Assistance in creating and managing post-commercialization surveillance reports for medical devices.
Support for pharmaceutical product surveillance, generating required reports for health authorities.
We handle regulatory matters during product importation, ensuring compliance for market entry.
We advise clients under regulatory sanctions, designing strategies to ensure due process and favorable outcomes.
For food products, we assist in registering manufacturing facilities as required by regulatory entities.
We review labels for regulatory compliance and create models for nutritional labeling, including nutritional tables, warning seals, and applicable claims.
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.
We assess the regulatory status of a client’s product portfolio and develop strategies for commercial viability.
We assist in obtaining toxicity reports and classifications for pesticide products.
For foreign companies unable to hold registrations, we offer hosting services, acting as their representative for regulatory purposes in the required countries.
We translate technical and legal documents for regulatory processes, offering both simple and official translations as needed.
We tailor regulatory strategies and provide specific solutions to meet our clients’ needs.
Products We Serve:
Products
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
Products applied locally to superficial parts of the body to clean, perfume, alter, and/or maintain their condition.
Products designed to clean, disinfect, and deodorize spaces and everyday household objects. This category excludes products with similar functions intended for industrial use.
Products such as disposable diapers, sanitary pads, tampons, and panty liners.
Products used to prevent and control any organism considered a pest, as defined by the relevant health authority.
Medical Devices
Products for prevention, diagnosis, and treatment of medical conditions without pharmacological, immunological, or metabolic actions.
Reagents used to analyze human samples for detecting pathogens, metabolites, or substances.
Medications and Biological Products
Products with synthetic components, available in various pharmaceutical forms.
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
Pharmaceutical products created using homeopathic techniques.
Medicinal products with active substances derived from plants.
Products that supplement or complement the normal diet of humans and/or animals.
Veterinary Products
Includes food, synthetic medications, biological medications, herbal medications, disinfectants, homeopathic products, and cosmetics for animals.
Includes raw materials, ingredients, pesticides, fertilizers, and bio-inputs.

Key People
Ana De la Ossa
Coordinator of the Regulatory Affairs Department
Isabel Sanín

Ana De la OssaCoordinator of the Regulatory Affairs Department
adelaossa@spiamericas.com

Isabel Sanín Director of the Regulatory Affairs Department
isanin@spiamericas.com
Regulatory Affairs Team
Isabel Sanín, Ana de la Ossa, Sandra Preciado, Mauricio Cortés, Juan José Barragán, Catalina Ospina Heidy Díaz, Alejandra Cristancho, Magali Trujillo
Testimonies
The staff is trained to provide added value to the service and address any questions that may arise.
I have nothing but words of gratitude for Álvaro and his entire team. I have always received excellent service, especially from Isabel and Sandra. If I had to rate them from 1 to 10, I’d give them a 15.
For me, SPI's main strength is its human resources, as they have the necessary knowledge to advise their clients on regulatory matters in each country in Latin America.
It is a reliable company with excellent customer service.
SPI in Numbers
Experience
