Services and Consultancy for Clinical Trials
GCP Audit:
- CRO :
- Investigator Site Audits
- Vendor Audits: Qualifications, full service ( Bioequivalence study,
- Documentation Audits
-Site Qualification Visit
Bioequivalence Audits
GCLP
GCP Staff Training
Quality Assurance Consultancy develops customized standard operating procedures (SOPs)
Any OTHER GCP Services.
* ANVISA, FDA, EMA, MHRA, ANMAT, and others
Summary of qualifications and experience
- Member of Society of Quality Assurance: Home to the World's best QA Professionals
-Independent auditor for international companies (USA, Italy, France, Canada, Switzerland, Hungary, and Germany)
-Internationally qualified independent auditor. Global Quality Assured for ICH GCP E6(R2)/(R3), ISO 9001:2015, ICH Q9, Pharmacovillence/Adverse Events, GCLP, Bioequivalence Study.
-Independent audit experience in Rare Disease, COVID-19, CAR-T therapy, Canabis, Bioequivalence studies, and others.
-Experience in Pharmaceutical Industry as Quality Specialist and Audits in Clinical Research.
-Experience in Research Center Management.
-Top Global Recruiter CKD Study.
-Experience in Clinical Research since 2011 in clinical studies of Cardiology, Endocrinology, Gastroenterology, Gynecology, Nephrology, Dentistry, Ophthalmology, Orthopedics, Pulmonology, Vascular, pain improvement assessment.
-Experience as Reporting Member of the Independent Ethics Committee of FMABC.
- Postgraduate in Clinical Research by Invitare Pesquisa Clínica, 2012.
- Graduated in Biomedicine from the Universidade Metodista de São Paulo, 2011.
- Started 3 Clinical Research Sites since your foundation.
Get in Touch with Us
We appreciate your interest in our services.
If you would like to learn more about our services or receive a free assessment, please fill out the contact form or contact by:
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