Brief biographies of the consultants involved in delivering our services and their specific areas of expertise.
Charley has an MSc in Pharmaceutical Manufacturing Technology and has over 25 years of experience in the Irish Pharmaceutical and medical device industry. He is a subject matter expert in local EU and UK country-specific import, licensing and distribution requirements.
He is also a Qualified Person as per Article 48 and a Responsible Person as per Article 79 of Directive 2001/83/EC. Charley has extensive consulting experience where he has assisted Irish, UK and European companies in setting up Quality Management Systems, qualifying their vendors, conducting detailed gap analyses and risk assessments and obtaining essential MIA and WDA licences to manufacture, import and distribute their products in Europe and the UK. |
Jitu is a highly qualified professional, with an MSc from Kings College London in Pharmaceutical sciences and with more than 30 years of experience in the UK pharmaceutical industry. His experience covers formulation design and development from pilot to industrial scale and end to end technology and product transfer of pharmaceuticals and medical devices in global markets such as the EU, US and Russia. He is an expert in approaching challenging problems using systematic solid problem-solving methods including implementing optimisation and validation strategies.
Jitu is also an experienced global auditor, has managed manufacturing sites including micronisation, tableting and coating. He is a self-driven director with strong project leadership skills and scientific background happy to tackle any challenging problems. |
Shyam Kohl Associate Consultant Shyam has worked for the past 12 years as a certified lead API auditor. He specialises in auditing active ingredient manufacturers in Asia and the Middle East to ICH Q7 and global GMP standards.
Shyam holds an MBA, is a qualified pharmacist and is also a Prince2® project management professional. He has worked for a number of global pharmaceutical companies including Sandoz, Dr Reddy's and Amdipharm Mercury group. |
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