logo header
logo header
Home
About Us
Our StrategyWhy UBGInternational PresenceCorporate Social Responsibility
Solutions
Sanitary Registration HoldingHealth SurveillanceRegulatory ManagementRegulatory Consulting
Success Stories
Resources
BlogNewsImportant Documents
CareersContact Us
EsEn
Adverse Event Report

Regulatory management and compliance with regulatory requirements in Latin America

At UBG Regulatory Advisors we comprehensively manage the obtaining, amendment, and maintenance of your sanitary registrations, ensuring compliance with all applicable regulatory requirements in each country.

Our technical and legal team supports you at every stage of the product life cycle, ensuring accurate documentation, agile processes, and verifiable results before health authorities.

Request regulatory advice
consiste

What does our regulatory management include?

Our regulatory management service is designed so that your company meets regulatory requirements efficiently and without setbacks.

We specialize in obtaining, amending, and maintaining sanitary registrations for pharmaceuticals, cosmetics, medical devices, phytopharmaceuticals, and dietary supplements.

We work strategically to reduce observations, optimize timelines, and ensure that every document submitted meets the technical and legal standards required by the competent authorities.

Benefits of our regulatory requirements management

holding 1

Full compliance

We ensure that every dossier complies with current sanitary regulations.

holding 5

Optimized timelines

More agile processes and a significant reduction in approval lead times.

holding 4

Country-specific adaptability

We apply tailored regulatory strategies according to local legislation.

holding 6

Ongoing follow-up

We track expirations and updates with periodic reports.

Process to ensure compliance with regulatory requirements

1

Initial assessment

Technical diagnosis of existing documentation.

2

Regulatory analysis

Review of local and international regulatory requirements.

3

Dossier preparation

Technical preparation and structuring of documents.

4

Submission to the health authority

Support during review and observations.

5

Post-approval maintenance

Renewal, updates, and validity control.

Proven results in regulatory requirements management

holding 6

Fewer regulatory observations

We implemented documentary quality controls that reduced observations issued by health authorities by 60%.

holding 1

Successful multi-market harmonization

We supported the simultaneous submission and approval of registrations in Ecuador, Panama, and the Dominican Republic.

holding 7

Optimized internal regulatory workflow

We designed standardized procedures that improved traceability and reduced approval times by 30%.

Meet all regulatory requirements with expert support

Request regulatory management advice

Explore our other services

holding 1

Sanitary Registrations

consultoria 1

Regulatory Consulting

vigilancia

SANITARY
SURVEILLANCE

We value your privacy
We use cookies to improve your browsing experience, show you personalized content or ads, and analyze our traffic. By clicking "Accept all" you consent to our use of cookies.
Customize Cookies

Need reliable regulatory advice? UBG supports you at every step.

Contact Us
  • Ecuador: Mariana de Jesús E7-8 y La Pradera, Edificio Business Plus La Pradera, Of. 605, CP: 170518, Quito - Ecuador
  • +593 2 600 3014
  • info@ubg.com.ec
  • Panama: Calle 74, San Francisco, Edificio Midtown, Oficina 1805 - DELCO, Panama City, Panama
  • El Salvador: San Salvador Final 83 Avenida Sur, No. 403, Segundo Nivel, Colonia Escalón, San Salvador, El Salvador.
  • Terms and Conditions
  • Data Protection Policy
  • Adverse Event Report
logo footer

© UBG REGULATORY ADVISORS. All Rights Reserved.