Susana Tavares is the owner of STavares Consulting

History

Stavares Consulting Unipessoal Lda, is research quality assurance consultancy, established in January 2024.

The owner is Susana Tavares, a pharmacist that worked 21 years in the pharmaceutical industry. Susana has been involved in the development of two Portuguese compounds market in Europe, US and many other countries including Japan. She has implemented quality systems in the research arena, namely on the pre-clinical, clinical and pharmacovigilance either in the headquarters as in the affiliates (these located in Europe, Africa, Latin America and US).

Since 2002, she managed more than 2600 audits and conducted more than 500 hundred audits, including for cause in 35 countries (including North, South and Latin America, India, Singapore, Taiwan, Russia, North and South Africa, Western / Central / Eastern Europe) and was involved in due diligences. Also hosted around 30 inspections and prepared more than 40 inspections. High experienced in the management of all QA activities, including, writing, reviewing and approving SOPs, management of deviations and change control and training. Participation in quality meetings with FDA and MCC were also part of her experience.

Now she is a trainer of RQA's "GCP Auditing: Principles & Practice" course, which runs two/three times a year in the UK or remotely and "GCP Introduction, Refresher & Hot Topics Course", which runs once a year remotely.

With all this background Susana decided to create her own company to provide the following services related to Good Clinical Practices, Good Laboratory Practices and Good Pharmacovigilance Practices:

Inspection readiness/host of inspections
System audits (including project management, study monitoring, pharmacovigilance, IMP management, quality systems, data management, statistics, medical writing)
Routine and for-cause investigator site audits (all phases of research)
Documental Audits
Evaluations of Pre-Clinical and Clinical contract research organisations (CROs), Phase I units, bioanalytical and central laboratories
Provision of cover for various clinical QA management activities whilst a new manager was being recruited
Remote assistance to help set up a clinical QA function in a new organisation
Development of a Quality Systems Harmonisation Plan to assist with the merger of two organisations
Creation quality assurance Standard Operating Procedures
Training of auditors in situ
GLP, GCLP, GVP and GCP training

Quality Assurance is the exclusive business. The office is located in Oporto (Portugal) very close to Oporto International Airport, affording easy access to international destinations.

The plan is to maintain in the future this small organisation to be extremely flexible and to adapt quickly to clients' needs. The company will always be very careful about the amount of work undertaken to ensure that the quality of what is delivered will never be compromised. The prime concern is always the satisfaction of the clients with the work undertaken and the company will do its utmost to ensure that they will be meet or exceed.

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