Pharmacovigilance & Drug Safety
| 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. |  |
| Cristina Santos Regulatory Affairs Contact: Sara Cristina Santos T: +33 (0)1 77 69 64 22 Head Office Portugal | Cristina Santos Regulatory Affairs is a new company based in France which provides regulatory affairs services and consultancy. We are also present in Portugal. With a wide experience in the field, we offer high quality and flexible support to the preparation of marketing authorization dossiers, submissions and variations, leaflet readability tests and pharmacovigilance. | |
| Cyton Biosciences Ltd Contact: Stuart Thomas T: +44 (0) 117 973 9036 2, St. Pauls Road | 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. | |
| Kompass Regulatory Services Ltd Contact: Barry Geoghegan T: 0906 66 34100. Ardsallagh Business Park, | REGULATORY & CLINICAL SERVICES Pharmaceuticals, Medical Devices & Combination Products & Auditing | |
| Pharmalink Consulting Contact: Kevin O’Toole T: +44 (0) 1628 860 300 Vandervell House | Pharmalink Consulting is the world’s largest independent Regulatory Affairs Consultancy. |  |
| 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: Natalie Grogan T: +44 (0)1209612650 Pool Innovation Centre | Created in 2001, TRAC provides a full range of EU Regulatory Affairs Consulting Services to the Pharmaceutical, Biotechnology, Healthcare and Medical Device Industries. Our portfolio of regulatory services covers all stages of the product lifecycle and is delivered by specialists in their field with the relevant knowledge and experience. TRAC takes a fresh approach to consulting, providing long term or interim regulatory resource off-site. We personalise every project to ensure it meets the exact needs of our clients and are committed to delivering exceptional service quality that will change the way you think about regulatory consultancy services. | |
| 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: Dr Chris Wainwright T: +44 (0)1628 530554 Wessex House, | Wainwright Associates provides consultancy to the pharmaceutical, medical device and healthcare industries. We offer a professional and flexible service that is customised to our clients' needs. Our consultancy service includes: Product Development Planning, Regulatory Affairs, Pharmacovigilance, User Testing, Licensing We are able to carry out both short and long term contracts and can provide additional resources for in-house projects or manage new programmes of work for you. Wainwright Associates consultants are highly qualified and experienced in most therapeutic areas. The company handles projects in pharmaceuticals, both small molecule and biotech, medical devices, diagnostics, herbals, food supplements and cosmetics. Wainwright Associates has a dedicated in-house team and a solid network of local advisors in over 60 countries of the world. |  |
