| Acerna Contact: Paul Larocque T: +1 905 472 5747
E: info@acerna.ca 19, Bryant Road
Markham (Toronto)
Canada L3P 5Y7
| ACERNA Inc helps global pharmaceutical, biological, medical device, natural health product, cosmetic, and food companies solve manufacturing, GMP, QSR, quality system, submission, and regulatory compliance issues.
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| Akos Contact: T: +44 (0) 1582 766339
E: group@akos.co.uk The Coach House,
The Grove,
Pipers Lane,
Harpenden,
Hertfordshire AL5 1AH,
United Kingdom
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| Ann Godsell Contact: T: + 44(0) 1442 866325
E: anng@dsl.pipex.com | | |
| Cambridge Regulatory Services Ltd Contact: Lisa Tietjen T: +44 (0)1480 465755
E: lisatietjen@cambreg.co.uk 2 Cabot House,
Compass Point Business Park,
St Ives,
Cambridgeshire,
PE27 5JL,
United Kingdom
| Cambridge Regulatory Services - Specialists in the field of Regulatory Affairs with clients ranging from start-up biotechs to world-renowned pharmaceutical companies.
A full service regulatory consultancy, helping pharmaceutical companies worldwide to gain approval for their medicines in a timely and cost-effective manner.
Do you need help with any regulatory aspect of your product development?
Not sure? Contact us today for 30 minutes' free advice.
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| Cyton Biosciences Ltd Contact: Stuart Thomas T: +44 (0) 117 973 9036
E: sthomas@cyton.com Hyland Mews
21 High Street
Clifton
Bristol
BS8 2YF
UK
| 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.
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| Deavin Associates Contact: John Deavin T: +44 (0) 173 026 2880
E: j.c.deavin@btinternet.com 35 Kimbers
Petersfield
Hampshire
GU32 2JL
| A consultancy specialising in regulation of Med Tech Products including cell therapy, borderlines and biologicals.
John Deavin (Proprietor) has been member of ABPI, EVM and EuropaBio Groups and Chair of TOPRA Devices Group; he set up the MSc in MTRA and is a regular lecturer at Cranfield and Wales Universities.
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| Diamond Biopharm Ltd Contact: T: +44 (0)1279 441616
E: info@diamondpharmaservices.com No.4 East Wing,
Gemini House,
Flex Meadow,
Harlow, Essex CM19 5TJ
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| Fannin Ltd Contact: Jayne Roberts T: + 353 1 290 7183
E: jayne.roberts@fannin.ie Fannin House
Sth County Business Pk
Leopardstown
Dublin 18
Ireland
| 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.
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| Forecom BioScience Ltd. Contact: T: 44 (0) 1483 546319
E: info@forecom.co.uk | | |
| Four Pillars Coaching Contact: Susan Botfield T: 01727 860700
E: susan@fourpillarscoaching.co.uk The Farmhouse,
Potters Crouch,
St Albans AL2 3NN,
UK
| Four Pillars Coaching Ltd is a consultancy providing Regulatory Affairs professionals with a confidential service to discuss personal development, leadership training, strategic planning and management issues. Certified qualifications in several coaching methods and 10 years experience in career development allow us to offer bespoke programmes to individuals, teams or companies.
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| Fred-CMC Contact: Frédéric David T: +33 961 048 954
E: frederic.david@fred-cmc.com 204 route d’Auribeau
06130 Gasse
France
| Fred-CMC is specialised in Chemistry Manufacturing and Controls. We help you with pharmaceutical development, regulatory intelligence and regulatory
strategies or document reviews / editing from Phase I (IMPDs) to Registrations (Module 3, QOS) and maintenance (compliance, variations).
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| Fulcrum Pharma Contact: T: +44 (0) 118 989 5680
E: | | |
| Jacobsen Pharma AS Contact: Anette Jacobsen T: +45 74 44 19 36
E: info@jacobsenpharma.dk Nørre Havnegade 108,
DK-6400 Sønderborg, Denmark
| 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.
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| Life Scientific Contact: Harvie Khaira T: +44 (0) 845 2703161
E: harvie.khaira@lifescientific.com 27 Old Gloucester Street
London
WC1N 3XX
UK
| Life Scientific offer Regulatory Affairs support to Pharmaceutical, Biotechnology, Animal Health, Medical Devices, Consumer Healthcare and Generics Companies.
We are one of the largest Regulatory Affairs consultancies in the UK, offering the complete range of services from strategic to maintenance support, available at short notice and at any level on or off site.
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| Mediplex Contact: Peter Hession T: +44 (0) 118 978 5323
E: p.hession@mediplex.com 48 Priest Avenue,
Wokingham,
Berks RG40 2LX, UK
| Dr Peter Hession, MFPM, MTOPRA, is an experienced pharmaceutical physician who has worked as an independent consultant since 1998, focussing on clinical regulatory affairs. Areas of expertise include: Clinical Overviews/Summaries; Paediatric Investigation Plans and waivers; assessing approvability of clinical programmes; responding to regulatory questions; regulatory hearings; Scientific Advice applications. mediplex.com
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| Medpace Switzerland GmbH Contact: Stephan Henauer T: +41 43 399 76 73
E: s.henauer@medpace.com Medpace Switzerland GmbH
Seestrasse 356
8038 Zürich / Switzerland
| Medpace is a global full-service CRO operating in 44 countries around the world (www.medpace.com). At the office in Zürich, a team of senior professionals with international experience and reputation provides advice and all services required to manage pharmaceutical development in Europe and the USA.
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| Medwise International Consultancy Ltd Contact: Dr John C T Lang DABT T: +44 (0)1759-380273
E: johnlang@medwise-international.com P.O. Box 17 Wilberfoss
York YO41 5YY
UK
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| Norpharm Regulatory Services Contact: T: + 00 353 52 38880
E: marygavigan@norpharm.ie Tullaghmeelan,
Grange,
Clonmel,
Co. Tipperary, Ireland
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| PAREXEL Consulting Contact: Chris Lindgren T: +1 978 275 0062
E: chris.lindgren@parexel.com 900 Chelmsford St.
Lowell, MA 01851
USA
| PAREXEL Consulting provides comprehensive product development services, helping biopharmaceutical and medical device companies shorten time-to-market and maintain product viability for the long-term. Through our unique fusion of scientific, regulatory, and business expertise, we help clients manage risk, and maximize product and portfolio value at every milestone and phase of development worldwide.
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| Pharmaceutical Development Services Contact: Janet Ellis T: +44 (0) 115 912 4270
E: janetel@pharmdservices.com BioCity
Pennyfoot Street
Nottingham
NG1 1GF
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| Pharmalink Consulting Contact: Kevin O’Toole T: +44 (0) 1628 860 300
E: info@pharmalinkconsulting.co.uk Vandervell House
Vanwall Business Park
Maidenhead
Berkshire
SL6 4UB
| Pharmalink Consulting provides all major Regulatory Affairs services in the fields of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, and Veterinary.
We provide top quality interim Regulatory Affairs staffing solutions in addition to our consultancy services.
We have offices in the USA, UK and India and a network of over 2,000 professionals worldwide.
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| PLS Regulatory Consulting Contact: Paul Sugden T:
E: paul_sudgen_30@hotmail.co.uk 27 Nursery Road,
Farncombe,
Godalming,
Surrey,
GU7 3JU
| Experience in mainstream pharmaceuticals, biotechnology, OTC, generics, medical devices, cosmetics.
My expertise covers:
- Strategic regulatory advice.
- Review of regulatory submissions.
- Scientific Advice meetings.
- Clinical trial applications.
- Centralised, MR and DC procedures.
- QOS, Nonclinical and Clinical Overviews, IMPDs.
- Maintenance activities.
- In-house training.
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| Ray Lindsay Contact: T: +44 (0) 20 7515 0932
E: raylindsay@aol.com 20 Luralda Wharf,
40 Saunders Ness Road,
London, E14 3BY
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| Speid & Associates, Inc. Contact: Lorna Speid T: Phone: +1 858 793 1295
E: lspeid@sndtm.com San Diego, California, USA
Mobile: +1 858 531 6640
| 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.
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| TRAC Services Ltd Contact: Vicky Kent T: +44 (0)1209 612650
E: info@tracservices.co.uk Chy Gwel
1 East Pool
Tolvaddon Business Park
Camborne
TR14 0HX
| 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.
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| UKR Regulatory Affairs Ltd Contact: Linda Woods T: +44 (0) 1869 247768
E: info@ukr.uk.com The Bull Pen
Home Farm
Banbury Road Caversfield
Oxfordshire
OX27 8TG
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| Undine Schachtschabel Contact: T: +44 (0)1753 578177
E: undine.schachtschabel@btinternet.com 126 Aspects Court,
Windsor Road,
Slough, Berkshire
SL1 2EZ
United Kingdom
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| VI.REL PHARMA Contact: Dr. Paolo M. Biffignandi T: +39 (0) 110 014 838
E: pbiffignandi@virelpharma.it Via Vittorio Alfieri,
28b - 10024 Moncalieri (TO),
Italy
| VI.REL PHARMA is a flexible structure and therefore we are tailored to meet clients’
requirements with a an understanding of changes in the regulatory environment.
- Preparation of Module 1-5 of the CTD, including e-CTD
- Nonclinical and Clinical Overviews & Summaries
- Regulatory submissions (national and European)
- Post marketing activities: variations, renewals, pharmacovigilance
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| Wainwright Associates Ltd Contact: T: +44 (0)1628 530554
E: enquiries@wainwrightassociates.co.uk Wessex House,
Marlow Road,
Bourne End,
Buckinghamshire,
SL8 5SP,
U.K.
| 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.
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