Based in Cambridge, UK, Global Regulatory Services (GRS) is a network of independent professionals and specialists providing clients all around the world with country-specific regulatory and quality compliance support across the whole life science sector.
Global Regulatory Services (GRS) was founded in 2007 by Bobby Deal, managing director, and shortly joined by Greer Deal, Director. Bobby launched GRS to provide services in regulatory affairs and quality compliance to the global life science sector including human and veterinary health and medical care, biotech, nutrition, digital health, IVD and MedTech companies around the world.
“We wanted to look beyond Europe and the US. We wanted to provide something that is truly global,” said Greer. “To achieve this, we have created a network of independent consultants who can speak the local languages and know the local culture and regulations.”
Working in the Nordic region
GRS has an office at Medicon Village in Lund and uses this as a base to support clients in the Nordic region.
“The Nordic region is a location of exceptional business development and growth. There have been – and will continue to be – a lot of innovation here,” said Greer. “The oil industry is not going to be around forever in this region, and the government is encouraging investment into biotech, pharma and medtech. We plan to be at the forefront, living up to our goal of ‘driving innovation to market success’.”
Breaking down the complexity
As technology advances, often outpacing regulatory changes, it becomes harder for companies to move products through the approval process and onto the market. In many cases, regulatory bodies are having to assess the registration of these products on a case-by-case basis. GRS can provide support for companies developing these more challenging products.
“We work alongside our clients who are developing products at the forefront of technology, and whose products often don’t have a neat regulatory pathway to market. We have teams of specialists who have both scientific skills and regulatory expertise, and who can communicate effectively with the regulatory bodies. This means we are up for the challenge of helping to ‘fine tune’ regulatory pathways and to get new-in-class products to the market first,” said Greer.
GRS’ local knowledge, combined with its regulatory expertise, means that the consultancy can produce submissions and communications that are of great help to the authorities as well as of significant value to their clients.
“The client is the expert on the science which has created their product, but they don’t always have experience in working with regulatory authorities. Our consultants can be more dispassionate about the product than the developers. They are engaged with the regulators and work to ‘translate’ the company’s output into regulatory language – they effectively act as interpreters,” said Greer, “presenting the science in such a way so that the regulators can readily understand the product and are reassured that it is efficacious, safe and of the required standard of quality.”
Greer’s advice for a company developing a product that comes into this ‘challenging’ or ‘borderline’ category is to engage with the regulatory specialists as soon as possible to ensure the product is defined correctly. These regulatory specialists can be found in-house or, more usually, are sourced externally. This is exactly the type of expertise which GRS provides on a day-to-day basis. GRS loves this type of challenge, recognising that ‘one size does not fit all’ and that each client is truly unique, requiring support and solutions which are bespoke to that client.
“By engaging regulatory specialists early, this will encourage investors who want to see a defined regulatory pathway in place and thereby help to secure funding. This early engagement will also help to define timelines and keep things realistic, and will make the overall regulatory process much easier,” Greer added. “Regulatory advice is often seen as a cost, but it really is an investment. By engaging the right expertise early in the process, it will save a company time and money and all being well, get your product onto the market ahead of your competitors”.