Abel Santos y Asociados

Industries

Services

STRATEGIES IN REGULATORY PROCESSES, QUALIFICATIONS, PRODUCT REGISTRATION, AUDITS, GMP MANUFACTURING AND UPDATING OF PRODUCT INFORMATION

We simplify the development and risk management processes in the pharmaceutical, food, cosmetic and medical products industries.

DEVELOPMENT

We provide consulting services, develop new formulations and update analytical and manufacturing methods.

CLINICAL TRIALS AND BIOEQUIVALENCE STUDIES

We provide consulting and coordination services for activities related to clinical trials and bioequivalence studies.

PHARMACOVIGILANCE

We provide consulting services regarding pharmacovigilance activities, elaboration and updating of Periodic Safety Update Reports (PSURs), elaboration and updating of Risk Management Plans (RMPs).

REGISTRATION OF LOCALLY PRODUCED AND IMPORTED PRODUCTS. PREPARATION OF INTERNATIONAL DOSSIERS IN CTD FORMAT

We are strategic allies for the planning and development of national and international protocols.

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27 years of
EXPERIENCE

We put our experience at the service of your company.

ACCURACY and
TRUST

We assist you in every step of the way with diligence and professionalism.

MULTIDISCIPLINARY
TEAMS

We provide a comprehensive, results-oriented outlook.

We are specialists

We have a team of experts in healthcare product regulation and health legislation.

We carry out qualifications under strict quality standards (solving the chain of procedures).

Our compliance standards allow us to prevent, detect and manage compliance with ethical standards in a concrete and comprehensive way.

We collaborate so that commercialization processes are seamless and have high quality standards.

Any questions?

How we work

STRICT CONFIDENTIALITY.

QUICK RESPONSE.

SYSTEMATIZATION OF ANALYSIS AND CORRECTION OF ERRORS.

FOCUS ON THE DETAILS OF THE PROCESS.

OUR MAIN FOCUS IS TAKING CARE OF YOUR COMPANY.