SpectRA Compliance
Boutique Consulting for Regulatory Affairs in Medical Device Industry

The ultimate mission of a medical device consultant is to help business owners and entrepreneurs develop business strategy and provide knowledge about global regulations while assisting them to achieve their objectives, profits, and growth goals. But very few consultants see the light of day, probably because most of them miss the mark when it comes to comprehending customer’s needs and delivering end-to-end solutions. The story of Andrea Pilon Artman, President & Principal Consultant of SpectRA Compliance, however, beats all odds as she believes in understanding the customers’ environment, their pain points, objectives, and subsequently crafting solutions that are scalable and sustainable.

The journey of Andrea traces back to the time when she was working as a reviewer for the United States Food & Drug Administration, where she developed a passion for regulatory science and policy. After working in multiple companies at multiple positions in the device industries, she realized that most of the medical device consultants were offering predefined services rather than analyzing client’s objectives, pain points, and delivering solutions specific to their requirements. “This was disheartening,” says Andrea. “Because clients pay a considerable amount of money to the consultants for developing a process specifically for them, but predefined services double the amount of work for the clients as they have to spend more time to integrate into their systems.”

Identifying this drawback as an opportunity, Andrea established SpectRA Compliance with a mission to help medical device and pharmaceutical companies effectively navigate and abide by the regulatory environment in the United States, Europe, and Canada.

Fast forward to 2020, SpectRA Compliance is at the forefront of offering a wide range of regulatory and quality services that are specifically designed to fit client needs. From Regulatory Submissions to sustaining regulatory and quality programs, SpectRA Compliance covers it all.

“Our objective is to develop resources, services, and strategies that are specifically designed for our clients, and once everything gets channelized, they can swing into action without any back end support,” states Andrea.

Andrea’s forte lies in presenting the information according to the FDA language. Many device companies have extremely intelligent PhDs and doctors, but unless one knows how to write an FDA language, the information is not going to get across to FDA. For instance, SpectRA Compliance can provide the full spectrum of regulatory submission support from a review of written documentation before final submission through complete authoring, submission, and regulator communications. The company’s extensive experience in designing robust regulatory infrastructures will help clients to streamline all regulatory activities and enhance the day to day activities.

Our objective is to develop resources, services, and strategies that are specifically designed for our clients

The company also utilizes its vast experience in the development and revision of Quality Management System documentation to create processes that are streamlined to fit its clients’ needs while ensuring their product remains compliant in the market. That’s not all; Spectra Compliance also offers a broad range of educational and training services coupled with high-quality documentation.

SpectRA Compliance caters their services mainly to small and midsize medical device and pharmaceutical companies. The effectiveness of SpectRA Compliance can be well-illustrated with a case scenario. One of the clients of SpectRA Compliance outsourced their regulatory department; however, while working with SpectRA, Ms. Artman helped them realize possible cost savings an in-house regulatory team could bring. In partnership with SpectRA Compliance, the client was able to form the regulatory department, implement the regulatory procedures, and train an in-house staff. In short, SpectRA Compliance went through all the steps to ensure that the correct regulatory controls were seamlessly integrated into the client’s business processes.

For the upcoming days, SpectRA Compliance intends to strengthen its skills rather than stretching its services and making its capabilities thin. As a testament to this viewpoint, the company wants to continue enhancing the innovation side of medical devices and mark their outright presence to Med-tech startups in the regulatory arena.