“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.