Mohsen established the International Compliance Service (ICS) in 1999 in California, USA, in an effort to support pharmaceutical companies facing critical quality and compliance challenges including 483 observations, warning letters, and/or consent decrees. In 2012 Mohsen reestablished the ICS Maven in Switzerland and since then he has been serving as the company’s Managing Director and Principal Consultant. Some of Mohsen’s recent projects included managing preparation of a large french biopharmaceutical company for initial FDA inspection and subsequent approval and launch of its first product in the US market. Additionally, Mohsen supported a global European based Pharmaceutical company to respond and remediate observations issued by the FDA leading to removal of a principle product manufactured in India from the US market. Meanwhile, Mohsen managed several projects for a number of European and US based companies with assessment and preparation of sites for FDA and European regulatory agencies inspection.
Those activities included but not limited to:
Performing the baseline assessment (audit) of sites compilate status
Comprehensive reengineering and implementation of QMS
Meeting with FDA agents in their home office presenting the sites and respective files
Additionally, Mohsen has managed the qualification of facilities, utilities, equipment, and associated computerized systems along with the respective process validation. He has also supported the preparation of BLA for submission to the US FDA, hosted successful the FDA preapproval inspections.
Mohsen has a wealth of experience in Data integrity assessment. He had analysed and reviewed manufacturing batch records and Quality Control data and packages for consistency and accuracy to support data integrity challenges by the FDA and EMA. He has reviewed product development packages, including clinical batch records, for completeness and data accuracy before submitting to the FDA.
Mohsen has developed and implemented sustainable quality management systems in several international companies. He has a proven track record of remediating critical manufacturing challenges and preparing sites for recertification by regulatory authorities (FDA). He is also fully conversant with the development and utilization of risk management tools. He has managed remediation processes for a number of FDA Consent Decrees.
Mohsen has in-depth experience in design, qualification, operation, and maintenance of bulk biotech manufacturing equipment, processes and utility systems, and associated quality systems for non-conformances, change controls, deviation, OOS, CAPA, Audit, etc.
Prior to ICS Maven, Mohsen worked as the Head of Global Quality Assurance at Sandoz Pharmaceuticals in Germany. He has also held the position of VP of Corporate QA and Compliance at Merck KGaA in Germany, VP of corporate QA at Serono Pharmaceuticals in Switzerland, and VP of Corporate QA and Compliance at Elan Pharmaceuticals in Ireland. During the late 80s and throughout the 90s, he held positions of increased responsibilities at Alza Pharmaceuticals, Fisons Pharmaceuticals, Glaxo Inc., and Burroughs Wellcome.