Latin America & West Coast US

GCP, PV, GLP & CSV

ADAMAS Consulting, the premiere independent provider of global Quality Assurance (QA) and Quality Management System (QMS) auditing and consulting, is pleased to announce the addition of several new QA experts to our expanding staff in the Americas.

Virginia Cajen is a Quality Assurance (QA) professional with more than 10 years’ experience in the Pharmaceutical, Biotech and Contract Research Organization (CRO) industries. Based in Buenos Aires, Argentina, she began her career as a Clinical Research Associate with a top 5 pharmaceutical company. Virginia became a QA auditor with a leading CRO and continued to expand her QA skills and expertise with two leading global pharmaceutical and biotech companies. Virginia’s broad experience includes the conduct of audits in more than 20 different countries in Europe, Asia, Africa and Latin America. She has additional experience in clinical trials; GCP and CSV auditing; and as a GxP trainer.

Above all Virginia brings an intimate knowledge of the nuances of regulatory compliance across Latin America.

Tonya Hamilton is based in California and began her career as a nurse in the United States Air Force. Tonya has conducted clinical investigations as a project lead and as a Quality Assurance auditor has lead a Clinical Quality Assurance Department, developing SOPs, conducting internal and external training, and utilizing a strategic approach to conducting clinical audits. In 2014, Tonya expanded her role in Quality Assurance when she joined the team at Loma Linda University as the Research Compliance Officer (RCO), responsible for conducting GCP and IRB audits, CAPA implementation, metrics tracking, hosting external audits, developing SOPs, and assisting with regulatory submissions.

Tonya is a member of the Society of Clinical Research Associates (SoCRA) and the American Society for Quality (ASQ).

Robert (Bob) Quinty is based in the Philadelphia area, with a specific focus on providing Pharmacovigilance audits and consulting services and has experience of pharma, consumer and medical device products. Bob has led teams in creating regulatory policies, procedures, documentation and regulations. He has also created, implemented, monitored, updated and managed corporate risk-based and regulatory-required audit and due diligence assessments programs including pharmacovigilance, affiliate quality systems, labeling, Employee/HR and Clinical privacy. Bob has prepared executive management reports summarizing the state of corporate compliance, risk / gap assessments and CAPAs.

Bob brings more than 25 years of extensive pharmaceutical industry experience encompassing global business compliance, global compliance auditing and regulatory affairs.

ADAMAS Consulting was founded in 1997 and has now grown into a global firm with staff based in the US, UK, mainland Europe, Latin America and Asia-Pacific.  ADAMAS now employs 42 permanent staff and has the largest in-house team of GCP, GVP, GLP and GMP auditors in the world.  We believe that our unique business model in selecting, recruiting and training our own staff is what makes the quality of our work stand out from all other providers of QA and QMS consulting services.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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