RICHMOND, Va. and LIVERPOOL, England, Nov. 28, 2023 /PRNewswire/ — Accorto Regulatory Solutions, LLC. (Accorto), a US-based regulatory firm specializing in helping small to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated products to market, and Inter Scientific Ltd., an industry-leading, ISO 17025/GMP-compliant testing laboratory and compliance firm based in the UK, announced today that they have entered into a strategic alliance agreement to provide single-point regulatory and testing solutions for customers in the pharmaceutical, medical device, nicotine, and cosmetics industries.
Pictured left to right: Dr. Vince Angelico, Jason Krull, Tom Beaudet, Mark Dignum, Russ Rogers, and David Lawson.
Through this strategic alliance, companies in the US, Europe, Middle East, and Asia will gain improved access to a seamless integration of Accorto’s regulatory strategy development expertise, US FDA regulatory application development & submission services, and project management solutions combined with Inter Scientific’s global state-of-the-art testing and regulatory compliance expertise in the UK, Europe and Middle East. The two companies aspire to use this alliance to streamline the regulatory application development process on behalf of global clients, providing a market leading turn-key solution for both regulatory support and associated analytical data development.
Inter Scientific co-founder David Lawson said, "We are thrilled to unveil our strategic alliance with Accorto. This collaboration represents a significant milestone, offering both new and existing clients a competitive advantage. By aligning with another industry-leading regulatory company that shares the same commitments to quality, urgency, and value, we are confident this will further elevate our standards and capacity."
Accorto and Inter Scientific’s collective service offerings will immediately benefit their clients in the following ways:
Expediting time-to-market while reducing overall project costs Mitigating potential risks of sub-optimally aligned strategies, proactively reducing the chances of experiencing costly setbacks and project delays Developing regulatory and product testing strategies that satisfy the requirements of multiple regulatory jurisdictions, streamlining client access to regulated global markets Providing full turn-key regulatory pathway determination, authoring, publishing, submission, deficiency responses and amendments for US PMTA’s, 510(k)’s, and NDA’s, UK TRPR, medical devices and medicines and EU TPD and EU MDR Developing all required analytical data across a broad range of validated analytical testing protocols to support regulatory applications Delivering insight into analytical results through out-of-specification investigations
"We could not be more pleased to be entering into our first strategic alliance with a company like Inter Scientific that has such a fantastic team. This not only provides our clients with the ability to collect data needed to prove the safety and efficacy of their products, but also allows us to shorten their regulatory application timelines, giving them a competitive advantage," said Tom Beaudet, CEO of Accorto. "We are continuously looking for opportunities to add value to the services we provide, and having trusted partners like Inter Scientific allows us to do just that."
This news comes shortly following Accorto’s announcement of appointing Dr. Kevin Lye to their newly established Medical Advisor role, as well as Inter Scientific’s expansion to a 10,000-square-foot bespoke facility in Liverpool, UK, which will house new in silico and in vitro toxicological services in addition to accommodating dedicated nicotine product and cannabinoid product laboratories. Inter Scientific also provides extractable and leachable analyses for evaluation of pharmaceutical and nicotine products, further expanding the abilities to demonstrate the appropriateness for the protection of public health (APPH) for the associated categories.
About Accorto Regulatory Solutions Established in 2021 in Richmond, Virginia, Accorto Regulatory Solutions specializes in helping small- to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market, as well as working with providers of FDA-regulated products and services to ensure they are operating in a compliant manner. The mission of Accorto is to provide unmatched service for clients, offering custom-tailored solutions to meet each client’s individual project needs, timeline, and budget. Accorto has a proven track record of success when it comes to FDA regulatory applications, achieving regulatory success for their clients in the medical device, nicotine, cosmetic, pharmaceutical, and alternative products industries.
Learn more about Accorto Regulatory Solutions at www.accortoreg.com.
About Inter Scientific With almost a decade of experience in regulatory affairs and analytical testing, Inter Scientific offers innovative solutions to ensure that products are compliant with Regulations, Directives, and standards. The company has extensive knowledge and expertise, as well as substantial analytical capabilities.
Inter Scientific values quality, which is why they proudly hold a variety of accreditations and certifications, including ISO 9001, ISO 14001, ISO 27001, ISO 17025, and Good Manufacturing Practice (GMP) as part of their Environmental and Quality Management System (EQMS).
Learn more about Inter Scientific at www.inter-scientific.com.
Media Contact: Kristina Haysmer, kristinah@accortoreg.com
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