Having 30+ years of combined experience of working in the Clinical Trials area, we conduct the GxP Audit & Consulting services designed to meet your organizations needs and will teach you all you need to know about the latest EU and U.S. requirements for Pharmaceutical GxP. At the same time we have the profound expertise in Clinical Trials area we continue to work with the number of planned and ongoing clinical studies in a Consultant role with our Partner CROs, ensuring the appropriately high level of the overall quality and professionalism in the Study Team. We are able to conduct the complex Audit and Consulting services (including but not limited to: GCP, GLP, GSP, GCDMP, GMP, GDP, GGP) both in the on-site and remote modes. In the context of Consulting we’re able to work both in the Ad-Hoc and Permanent Processes Support approaches
Audit Programmes
We’re able to conduct the external GCP, GLP, GSP, GCDMP, GMP, GDP, GGP audits both for CROs and Pharmaceutical
companies with the Worldwide presence.
Audit – the official inspection planned, conducted or organized by the ACROSS Global organization (by its internal resources of with the participation of the external experts / auditors) with the following objectives:
a) To assess whether the process / system described in the appropriate SOP is suitably designed, controlled, maintained and documented to fulfill the objectives for which it has been set up.
b) To assess compliance of tasks / operations with relevant SOPs and regulations.
c) To identify gaps, weaknesses, root causes and recommend areas and measures for process / system improvement.
Auditor – the AGA employee / contractor or an appropriate external expert involved into the Audit preparation, conduct,
reporting and follow up actions.
Auditor Profiles
Our multi-national and multi-country team has combined 60+ years experience in Clinical Trials area – as well as detailed understanding of all of the industry nuances “on a findgertips”.
Andrea Saud Martinez
QA Auditor
Andrea is a Quality Assurance professional with over 30 years’ experience in Pharmaceutical Industry and 16 years’ experience in Quality Systems Development and Management with emphasis on the United States Food and Drug Administration, ICH, global requirements for Good Clinical Practices with emphasis to Latin American countries. Andrea’s multilingual skills allow her to perform GCP site audits in Portuguese, Spanish and English speaking countries. Andrea is very much used to travel covering Latin American countries. Andrea has extensive experience and tracks expressive records of 140 GCP site audit and vendor audits performed to date. Andrea is graduated by Paulista University (Brazil) in Pharmacy and Biochemistry; she holds a Specialty degree in Clinical Pathology and a Master degree in International Businesses.
Steven Bukvic
The CEC, QA Auditor
Steven Bukvic graduated from Coventry University in 1982 with a degree in Applied Biology. After serving in the commercial sector of the UK motor industry for 8 years, Steven joined the Pharmaceutical Industry in 1990. For the next 30 years Steven’s career in the Pharmaceutical / CRO sectors has covered a broad range of disciplines within the field of clinical research. He has also had extensive geographical exposure having worked in the UK, US, Germany, Singapore, China and the CIS.
In his capacity as Regional Clinical Quality Manager with Schering-Plough/MSD, Steven successfully delivered on a variety of GCP audits (both internal company audits as well as site audits across Southeast Asia).
Charles Oviawe
QA Auditor
Charles is a Quality Assurance professional with over 20 year’s experience in Quality Systems Development and Management with emphasis on the United States Food and Drug Administration, ICH and global requirements for Good Clinical Practices, Good Laboratory Practice for Nonclinical Laboratory Studies, Good Pharmacovigilance Practices, Clinical Laboratory Improvement Amendments, current Good Manufacturing Practices and Computer System Validation.
Violeta Ristic
QA Auditor
Violeta is the hard working and dedicated professional with ambition for long-term work in Clinical Research.
Akiko Shibuya
QA Auditor
Akiko has nearly 20 years of experience in a series of drug development-related activities, including clinical monitoring, project management, PMDA review management, and GCP inspection management in the clinical development divisions at a pharmaceutical company. Furthermore, she has experiences in supervising PV and PMS divisions. Based on her various experiences, she proposes the most appropriate audit plan that meets the client’s needs, taking into consideration the Japan’s regulatory situation.
Natalya Makeeva
QA Auditor
More than 20 years ago Natalya started her career in clinical trials as Data management specialist at little local Clinical Research Organization. Continuing her professional journey, Natalya obtained experience of work both in little local and big global pharmaceutical companies and CROs, including Pfizer, Astra Zeneca, Merck Serono, PPD, Nearmedic. In Natalya`s career history there are different positions held within clinical trials area: in the frames of Data Management – since 2003, Clinical Monitoring – since 2006, Project Management – since 2009, Trainings – since 2012, Quality Assurance – since 2015.
Joseph Yammine
QA Auditor
Process & Quality Engineer possessing large expertise in the Quality Management Systems, Auditing, Consultancy, Organizational design and restructuring, compliance, process reengineering, working with a diversified portfolio of clients within Europe, Middle East, Gulf and Africa With my varied experience in several industries, starting by the Healthcare, Logistics, Quality and Education and covering different geographical areas, my professional objective is to assist small to large organizations in designing their systems and structure, so they may be able to transform and upgrade their business.
Training Instructor Profiles
Ahmad Kamal
GxP Trainer
Ahmad Kamal, Ph.D., is a seasoned professional, having over 14 years of invaluable experience in the Clinical Research and drug development industry. With a strong educational background as a Pharmacist, Ahmad has honed his expertise in drug development and its various phases through his tenure in multinational pharmaceutical, biotech industry and clinical research organizations.
Steven Bukvic
The CEC, GxP Trainer
Steven has a passion for training and is the founder of the Pan-Asian Clinical Research Association (PACRA) which was established in 2009. With a clear British accent, Steven has adjusted his speech over the years to accommodate the needs of non-native English speakers. He is regularly complimented for his clear, understandable, delivery style. In terms of module content, Steven’s training modules have clearly defined objectives, well structured content (with appropriate ‘sign-posting’), interactive exercises as well as ample time for Q&A.