Abel Santos y Asociados

REGULATORY

ARGENTINA

Consulting services on health regulations that govern the work of companies dedicated to the area of health. Consulting services on import/export and/or preparation of pharmaceutical, dental and cosmetic products, in vivo and in vitro diagnostic reagents, household cleaning products, nutritional/dietary products, herbal medicine, food and medical technology.

Qualifications.
Health Regulations.
Product Registration.
Registration Audits.

LATIN AMERICA

Coordination of regulatory activities in Latin American countries.
Health Regulations.
Product Registration.
Preparation of International Dossiers (FDA, EMEA CTD)

CRO (Contract Research Organization).

CLINICAL RESEARCH

Our work philosophy.

Concept of “PARTNERSHIP” with the client.

In harmony with the local manager of our client’s project, our goal is to become the operational arm of their work team. For that reason, we establish a fluent communication flow with our clients, in order to ensure effective and timely monitoring of all aspects related to the development of the research plan.

Not only do we promise to obtain solid and reliable results, but we also ensure that these are the consequence of the strict application of our work philosophy.

Consulting services on local planning of clinical research.

Modules adapted to the needs of the sponsor.

Coordination and monitoring by expert professionals in clinical research.

Absolute confidentiality.

Reliability in clinical research monitoring.

Professional reliability in representing the sponsor.

Compliance with the requirements and deadlines agreed upon.

Quality Assurance and GMP.

Medical

Architecture

Planning development for ductility in the creation of new plant projects.

Follow-up and monitoring of compliance with Good Manufacturing Practices.

Project and elaboration of technical construction documentation.

Management of new works or reforms.

Consulting services for hiring construction companies and suppliers of construction services and supplies.

Pharmacovigilance

Preparation of Periodic Safety Update Reports (PSURs): adaptation of parent company reports to local requirements. Preparation of Risk Management Plans (RMPs) and follow-up of local actions: adaptation of corporate RMPs to local format and requirements.

Report of adverse events from clinical studies to ANMAT and CCIS

Pharmacovigilance audits:

– Consulting on local regulations regarding pharmacovigilance.

– Review of the documentation to be presented at the audits.

– Compliance with the corporate guidelines of the documents issued by the laboratory.

– On-site presence of our professionals on the day of the audit.