
Proactive regulatory strategy
We anticipate regulatory observations and reduce response times.
At UBG Regulatory Advisors we provide specialized pharmaceutical consulting in regulatory compliance, regulatory planning, and technical product management.
We analyze each market and design tailored strategies so that your company can obtain, maintain, and monitor its products efficiently and safely.
Our pharmaceutical consulting service is designed to support laboratories, manufacturers, distributors, and healthcare startups in meeting the technical and regulatory requirements of each country.
We assess how your products interact with local regulations and help you anticipate observations or risks.
Our approach combines regulatory knowledge, technical expertise, and strategic foresight, accelerating product approvals, optimizing processes, and ensuring sustained compliance with health authorities.
We anticipate regulatory observations and reduce response times.
We organize and validate dossiers according to international regulations.
We have experts in pharmacovigilance, technovigilance, and quality control.
Regulatory compliance advisory across Latin America and the Caribbean.
Initial analysis of the product and its regulatory requirements.
Customized planning by country and sanitary category.
Technical preparation and documentary validation.
Management of filings and observations.
Ongoing updates and post-approval support.
We implemented regulatory strategies that reduced the average approval time for medicines in Ecuador by 35%.
We developed templates and checklists that improved the technical consistency of dossiers submitted to ARCSA and MINSA.
We supported the harmonization of pharmaceutical products in 5 countries simultaneously, with 100% compliance on regulatory observations.
