Critical Compliance
For All Things Therapeutic

Maintaining the highest standards of quality is paramount when releasing a medical device or pharmaceutical drug. Manufacturers and suppliers need time and expertise to manage this aspect of development. Pharmaceutical companies, and therapeutics producers and distributors are increasingly seeking the guidance of professional consultants.

One such expert is Ben Cowburn, a highly experienced medical and pharmaceutical manufacturing professional, and alumni of the University of Newcastle, located in Cooranbong, New South Wales, Australia.

Through his acumen in production quality and regulatory affairs for medical devices and medicines, Ben started the consultancy business, Critical Compliance. He ensures that information from various medical research studies retains its value, and saves time and resources for clients by ensuring that all documentation is compliant with the latest regulatory requirements.

Ben deals with customers at every level, and believes that remaining active within the industry is a top factor in delivering high-level consulting, auditing, and validation services in the medical devices and medicines manufacturing sector. A member of the Association of Therapeutic Goods Consultants (ATGC), he maintains close relationships with reputable medical and pharmaceutical organizations, and uses the experience to further amplify his consultancy practice. This ensures that clients receive the very best in manufacturing quality and regulatory affairs consultancy services.
“The experience I gained in quality assurance and regulatory affairs roles within companies like Slade Health and Logikal Health Products, allows me to stay up-to-date with the newest regulatory requirements and industry practices, and offer a service to individual proprietors and smaller companies at the highest standard,” says Ben, therapeutic goods consultant and founder at Critical Compliance.

One provided service is guidance and support for importers seeking to safely import personal protective equipment (PPE), as well as antibody and antigen test kits, into the Australian market during the pandemic.

With a strong emphasis on compliance and documentation, Ben ensures that clients follow all local requirements to minimize the risk of fines and regulatory action from authorities.

Ben also uses his extensive experience to assist innovators and inventors in navigating the trial-and-error phase of their projects.Critical Compliance ensures that all standards and regulatory requirements are addressed, to maximize the chances of successful market access.

“The regulatory environment is becoming more complicated, and we will remain focused on helping people navigate the pathway forward where possible,” states Ben. When queries are outside its knowledge base, the company refers clients to other qualified consultants within the ATGC. “The strategy should always be in the best interests of the client,” elaborates Ben.

For a Sydneybased medical device consumables importer looking to venture into manufacturing, Critical Compliance was engaged to work with their quality manager to build a management system and validate the newly constructed cleanroom, as well as production and sterilization processes. Conscious that the client engaged a notified body to perform a conformity assessment audit, it partnered with the quality manager to review, improve, implement, and finalize the validations to complete the project within a limited timeframe. Requirements included designing and validating the ethylene oxide sterilization process needed for some of the planned products.

Several audits of the quality management system were completed, to help enhance existing procedures. The client also tasked Critical Compliance with compiling the medical device's technical files array, which involved writing most of the required documentation. The client easily passed the audit and received its conformity assessment certificate to manufacture medical devices.

For a pharmaceutical company, Critical Compliance addressed a dilemma involving ethylene oxide sterilization of a finished product. An uncommon problem under normal circumstances, the client had to find a solution that would prevent the primarily liquid product from being damaged by the sterilization process, whilst sterilizing of other aspects of the product. The validation had two significant challenges, firstly, the liquid volume within the sterilization load created a significant heat sink which challenged the sterilization process. And secondly, if the gas content penetrated the needle port of the product and infused into the liquid component, it would effectively destroy the product. Working with the R&D team, Critical Compliance formulated a unique set of sterilization parameters and adapted them to the process and equipment used at the local sterilization supplier's facility. It also oversaw the implementation of the validation process and the eventual completion of the entire project.

In another case, Critical Compliance was approached by a veterinary medical products manufacturer that had run aground after an audit finding concerning their terminal sterilization process using radiation.Through its many years of working with radiation-based sterilization processes, Critical Compliance was able to provide a solution that was “outside the box Instead of relying on a traditional method involving carriers that rotated around the radiation source in a controlled manner, it brokered a deal with the local supplier of sterilization services to manually place and monitor stock within the sterilization chamber. Avoiding the need for excessive dummy stock to meet capacity requirements, the client was able to save costs, even when each box had to be dose mapped for every sterilization process. The project was a success, with reduced expenditure and processing time, whilst achieving sterility assurance.

Looking purely at medical device trends in Australia, Critical Compliance is starting to receive numerous queries about navigating the Australian Unique Device Identification (UDI) system that will become compulsory for many products in 2024. Another area, in which the company anticipates it will play a notable role, is for medical device sponsors who need to change the manufacturer evidence that supports their local registrations. From a sponsor perspective, Critical Compliance will help them push past their set-and-forget mentality as they transition from the European MDD to the latest MDR certification.

As we move into the future, Ben is actively seeking to collaborate or partner with other consultants to expand the influence and impact of Critical Compliance. In his view, an expanded team with similar values, that understands and appreciates the work, is crucial to delivering future projects with the utmost care and attention.
Critical Compliance will often provide free guidance to local innovators and inventors seeking access to medical technology commercialization in Australia. Only after an initial discussion, and if additional services are required, will the company charge a fee.

Ben and his team remain committed to serving the medical device and pharmaceutical industry with the highest level of expertise and professionalism. Through their unwavering dedication and focus, Critical Compliance continues to be a trusted partner in helping clients navigate the complex regulatory landscape and achieve their goals.