Services List
| Service | Description | Further Information |
|---|---|---|
| Cambridge Regulatory Services Ltd Contact: Lisa Tietjen T: +44 (0)1480 465755 2 Cabot House, | Cambridge Regulatory Services - Specialists in the field of Regulatory Affairs with clients ranging from start-up biotechs to world-renowned pharmaceutical companies. |  |
| Cyton Biosciences Ltd Contact: Stuart Thomas T: +44 (0) 117 973 9036 Hyland Mews | Cyton Biosciences Ltd is a leading European consultancy providing specialist product development and registration services to the global healthcare and animal health industries seeking product authorisations in Europe. Their expertise covers all therapeutic classes, product types and delivery routes, as well as preparation of all types of marketing authorisation applications. | |
| Fannin Ltd Contact: Jayne Roberts T: + 353 1 290 7183 Fannin House | Fannin is a leading healthcare provider in Ireland and the UK and can offer Regulatory, Pharmacovigilance and User Testing Consultancy services within the EU. Fannin has a highly skilled and experienced Regulatory Team in place. We have over 45 years of combined experience and operate in the UK and Ireland. |  |
| Jacobsen Pharma AS Contact: Anette Jacobsen T: +45 74 44 19 36 Nørre Havnegade 108, | Regulatory affairs specialists in Scandinavia and EU.. We offer support on applications for marketing authorisation (national, MRP, DCP), readability testing of Patient Information Leaflets, pharmacovigilance, eCTD, variation and renewal applications, medical translations and more. | |
| Speid & Associates, Inc. Contact: Lorna Speid T: Phone: +1 858 793 1295 San Diego, California, USA | Speid & Associates, Inc. is a privately held regulatory affairs and drug development consultancy based in San Diego, California. Speid & Associates assists life science companies move new chemical entities to the finish line expeditiously by developing effective global regulatory strategies. The Company works at all phases of drug development and has experience working with all major regulatory authorities. | |
| TRAC Services Ltd Contact: Vicky Kent T: +44 (0)1209 612650 Chy Gwel | Created in 2001 TRAC has grown enormously in experience and capacity. We have received several prestigious awards and achieved both IIP and ISO-9001 accreditations. TRAC offers professional services that are both personal and innovative. You can be confident of our ability to assist you with every aspect of your regulatory needs. | |
| VI.REL PHARMA Contact: Dr. Paolo M. Biffignandi T: +39 (0) 110 014 838 Via Vittorio Alfieri, | VI.REL PHARMA is a flexible structure and therefore we are tailored to meet clients’ - Preparation of Module 1-5 of the CTD, including e-CTD | |
| Wainwright Associates Ltd Contact: T: +44 (0)1628 530554 Wessex House, | We are a team of highly skilled consultants in product development, regulatory affairs, pharmacovigilance and licensing relating to medicinal products, medical devices and other healthcare products. Services include regulatory strategy/planning, assessment of scientific data, preparation and submission of clinical and marketing dossiers (including e-CTD publishing), appeals, licence maintenance, leaflet user testing, quality audits and training. |  |
