GRS is a community of reputable independent professionals and specialists throughout the world. From the outset we have provided our clients with ‘on the ground’, country-specific knowledge. We have found it invaluable to have these local contacts in order to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission.
In response to our clients’ needs, we frequently operate at the forefront of technology often dealing with the more 'challenging' medical products and those which are considered to be 'borderline'. Today's advances in technology are phenomenal and, invariably, more products become 'borderline' as regulations are unable to keep up with the changes. In the majority of these situations, the regulators are considering the registration of products on a case-by-case basis. Therefore, we have established teams of specialists who have both scientific skills and regulatory expertise with the ability to communicate effectively with the regulatory bodies so as to achieve the best outcome for our clients.
These teams operate in the following areas:
- Advanced Therapy Medicinal Products (ATMPs)/cell therapies/biologics
- Digital Health
- Early stage development (product and/or company) offering strategic advice
- Functional foods/nutraceuticals/food supplements
- Generic medicines and Biosimilars
- GxP (Good Practice quality guidelines and regulations, for example: Good Manufacturing Practice)
- Herbal and traditional medicines/natural products/botanicals
- Medical devices/diagnostics/combination products
- Nanotechnology/Nanomaterials
- Paediatrics
- Pre-clinical
- Stem cells/regenerative medicine
- Veterinary products
Our professionals and specialists are highly experienced with all types of procedures and registrations, including:
- Abbreviated New Drug Application (ANDA)
- Biological Licence Application (BLA)
- CE Marking; Centralised Procedure (CP)
- De-Centralised Procedure (DCP)
- EU Notified Body submissions
- Investigational New Drug application (IND)
- Marketing Authorisation Application (MAA)
- Mutual Recognition Procedure (MRP)
- New Drug Application (NDA)
- Scientific Advice (EU and US)
- US 510(k)
The GRS community includes ex-FDA and ex-MHRA employees, food scientists, herbal experts, toxicologists, world renown stem cell scientists, pre-clinical advisers, Qualified Persons (QP), Expert Witnesses, medical experts and validators (with many authoring papers in their particular field of expertise). Our personnel are experienced in all types of submissions, are comfortable in advising on the best route to market and conducting due diligence activities.
