FQS
Building Compliance from the Core

One of the biggest challenges for pharmaceutical companies based in the UK today revolves around the policies of Brexit. Taking the example of an organisation that holds a wholesale distribution authorisation (WDA) licence or an MIA (Manufacturers Imporers Authoristaion for human medicine, Irene Frisby, an active qualified person (QP) and responsible person (RP), expresses the difficulties in operating efficiently. “A recent example of aiding a client who were a WDA licenced company and MAH whereby the QP certification was subcontracted out. They wanted more control over their distribution processes,” she says. Moreover, they found it to be increasingly problematic to meet release deadlines Brexit’s regulatory changes and sought to obtain manufacturers and importers authorisation (MIA) in Ireland. At this point, Irene’s company, FQS, offered the pharmaceutical corporation a slew of comprehensive consulting services that addressed all its needs and accordingly advised on the best technologies and practices to employ. FQS also managed to successfully achieve a good manufacturing practices (GMP) certificate and an Manufatuerers Importers Authorisation for the client and empowered them to release their products into markets across the European continent. After implementing the changes suggested by FQS’ staff, the pharmaceutical company made a seamless transition to Ireland and improved their manufacturing and distribution efficiencies multifold. And this level of service by FQS can be expected by any organisation seeking to bolster their areas of operations, including compliance, training, and remote support and consultations.

Established in 2005, FQS is the result of Irene’s longstanding experience as a consultant when she noticed a niche market for contract QPs and RPs, among other boutique services such as qualification and validation including onsite temperature and relative humidity mapping. FQS’ specialty lies in its team of diverse, multilingual staff who develop cost-effective and surefire strategies to help pharmaceutical enterprises employ the best solutions that improve productivity across a client’s enterprise. And ensuring adherence to all regulatory guidelines with no margin for error is absolutely critical for FQS. “One of the company’s main goals is to focus on improving compliance in an efficient effective manner within the pharmaceutical manufacturing and distribution space,” adds Irene.

One of the company’s main goals is to focus on improving compliance in an efficient effective manner within the pharmaceutical manufacturing and distribution space

FQS contract QPs and RPs, offering support to clients from a professional who is registered with the Health Products Regulatory Authority and active on licences for supply to European and export market. The QP is tasked with the responsibilities of approving medicinal products and collaborating with quality management system providers for numerous markets across the globe. This service includes the responsibilities of implementing and maintaining manufacturing licences, while overseeing the tasks of quality assurance, packaging, contract manufacturing, and clinical trials as well. The contract RP services on the other hand help clients by diligently managing their wholesale licencing status to procure, hold, supply, and export pharmaceutical goods with 100 percent compliance. FQS works closely with each of its patrons to understand how they operate and approaches their compliance needs accordingly.

The company also specialises in aviation security and perfectly caters to the requirements of the Irish Aviation Authority through its training in aviation standards and competencies. FQS is an approved security training organisation (ASTO) providing aviation security training. “Our team is complemented by a broad group of associates working across all areas of the aviation security field. We collaborate with industry and regulatory bodies to ensure the delivery of end-to-end compliance, meeting every legal requirement for aviation security,” expresses Irene. Furthermore, FQS is currently collaborating with a Columbiabased pharmaceutical manufacturer that exports products into the EU. “FQS is upskilling the client to open other opportunities within the EU. We are concentrating on bringing their technical team up to EU cGMP standards and expectations,” states Irense.

With such an intuitive portfolio of services, and more to be added soon, FQS is gearing up to drive innovation for compliance throughout Europe. The company intends to build compliance within the core of pharmaceutical and healthcare manufacturers, creating a safe and profitable ecosystem for all parties involved. Moving forward, FQS is expected to expand into newer locations as well as market segments. Location is no longer an issue as remote support is now a viable option with site visits reduced to only when and where needed. “Regulations for cosmetics and medical devices are becoming more challenging to comply with, and organisations will require assistance in understanding the new and changing legislations concerning the same,” says Irene. FQS seeks to reinforce its clients’ ability to conform to new laws all the while delivering compliant medical products to consumers all over the world.