Global QMS Development and Provision of Quality Assurance Personnel for a Company Acquiring a Commercially Distributed Biosurgery Product
A rapidly growing pharmaceutical company acquired a medicinal product that was already on the market and globally distributed, with the aim of becoming a global leader in innovative surgical technologies. The company reached out to SFL to assist with establishing a global Quality Management System (QMS) to market their products in Switzerland, the EU and globally.
SFL QA team identified the required Swiss Establishment license based on the company’s business plans and needs. The SFL team established from scratch a customized QMS with a global scope and performed all necessary activities to obtain the applicable license for their Swiss affiliate: application for the license, inspection preparation activities, drafting local Swiss documents, auditing applicable partner companies, establishing Quality Agreements with partner companies, and hosting both the initial Swissmedic inspection to acquire the license and the follow-up Swissmedic inspection one year later.
SFL personnel have acted and continue to act as the Swiss Responsible Person and Deputy Responsible Person for the company’s Swiss affiliate since the initial Swiss Establishment license application until present. Local Swiss activities have included local customer qualifications, local market release of product batches, and oversight of product returns and complaints from the Swiss market.
SFL have also assisted the company with establishing their key local European affiliates, including full inspection readiness support for (1) the company’s Germany affiliate applying for a manufacturing license and GMP certificate, (2) the company’s Austria affiliate applying for a Wholesale Distribution Authorization, and (3) the company’s UK affiliate applying for a Wholesale Distribution Authorization.
Multiple SFL personnel have concurrently acted as Quality Managers for the company’s global team, reporting directly to the company’s Head of QA. SFL personnel directly managed global activities including, but not limited to, qualifying global wholesalers and distributors, drafting and finalizing Quality Agreements with global wholesalers and distributors, coordinating activities between local and global Quality teams, overall maintenance of the global Quality system by executing all applicable QMS processes (Employee Training, Risk Assessments, Change Controls, Deviations, CAPAs, Product Quality Complaints, Computer Systems Validation, etc.), and attending and providing feedback during periodic global strategy meetings with the company’s management.
SFL personnel also act as local Responsible Persons and Quality Mangers for the company’s UK affiliate and Spain affiliate since initial establishment of the project.
The clients have been highly satisfied with the long-standing and extensive SFL support, with collaboration still ongoing.