Regulatory Affairs in Paraguay: Product Registration & Health Compliance

At Escalada, we understand that the regulated sector (Pharmaceuticals, Cosmetics, Food, and Agrochemicals) requires absolute technical precision. Sanitary Regulation is not just paperwork; it is the guarantee that your product will reach the Paraguayan market safely, legally, and profitably.

Under the direction of Mr. Arnaldo Escalada and our technical team, we offer integral solutions for international companies looking to operate before DINAVISA (Health Authority), SENACSA (Animal Health), SENAVE (Plant Health), and the MSPBS (Ministry of Public Health).

Comprehensive Management before DINAVISA, SENACSA & SENAVE

We manage the entire life cycle of your company and products, guaranteeing compliance with current regulations in Paraguay. We act as your local bridge to the authorities.

Company and Product Registration

We process establishment licenses and Sanitary Registrations for:

Pharmaceuticals and Medications.
Cosmetics and Hygiene Products.
Medical Devices (Technology).
Dietary Supplements.
Food and Beverages.

Technical Direction & Regency (Mandatory Local Rep)

Paraguayan law requires a local professional to sign for your products. We offer the service of Technical Regency before regulatory institutions to ensure a safe operation compliant with local standards.

Import and Export Management

We handle the evaluation and obtaining of critical licenses before DINAVISA, SENAD (Anti-Drug Secretariat), and ARRN (Radiological Authority), facilitating the international trade of your goods.

Strategic Consulting & Registration Hosting

We protect your property and economic rights, ensuring a smooth entry into the market without legal friction.

SANITARY REGISTRATION HOSTING (Legal Representation)

Do you want to start your business in Paraguay but haven’t incorporated a local company yet?

We offer the REGISTRATION HOSTING service. Under this representation figure, Escalada holds custody of your registrations (for medicines, cosmetics, or medical devices), allowing you to import and sell your products immediately through local distributors without waiting to set up your own corporation.

360° Regulatory Advisory

We provide specialized consulting on the manufacturing, distribution, and purchase of chemical and industrial products. Whether it is local production or importation, we accompany you at every strategic stage of the sector.

“Regulatory compliance is the passport for your product. Without it, there is no market. We ensure your passport is stamped and valid.”

Arnaldo Escalada

Lawyer & Regulatory Expert

Quality Assurance and Good Practices (GMP)

Regulatory Affairs in Paraguay: compliance is essential

Success in the health sector depends on quality. We help your laboratory, warehouse, or establishment reach international standards required by Paraguayan Law:

Good Practices (GMP / GSP):

We implement and audit Good Manufacturing, Storage, and Distribution Practices.

Pharmacovigilance:

Integral management of product surveillance before DINAVISA to guarantee post-marketing safety.

MSPBS Authorizations:

Specialized advice for hospitals, clinics, optics, gyms, and health centers.

Why entrust your Regulatory Affairs to ESCALADA?

In the health sector, a documentary error can mean months of delay and millionaire economic losses. At ESCALADA, we combine legal experience with technical regulatory knowledge to offer you:

Legal Security:

Shielding against inspections and government audits.

Agility:

Deep knowledge of the internal processes of DINAVISA and SENACSA.

Business Vision:

We don’t just register papers; we help you enter the Paraguayan market in the most efficient way possible.

Frequently Asked Questions about Sanitary Regulation (FAQ)

What products require Sanitary Registration in Paraguay?

Almost all products that have contact with human or animal health, including medicines, cosmetics, medical devices, dietary supplements, household cleaning products (domisanitarios), and processed foods.

What is "Registration Hosting"?

It is a service by ESCALADA for foreign companies that are not yet physically installed in Paraguay. We act as your legal and technical representatives, holding the title of the registrations so you can export to Paraguay and sell your products legally through local distributors immediately.

How long does a Sanitary Registration take before DINAVISA?

Deadlines vary according to the complexity of the product (a generic medication takes longer than a cosmetic), but our professional management focuses on optimizing times and avoiding rejections due to incomplete documentation.

Do you handle permits for Clinics and Hospitals?

Yes. We manage authorizations before the MSPBS (Ministry of Health) for a wide range of establishments, including medical offices, diagnostic centers, optics, and ambulance services.