| 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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| Acta Pharma Services Ltd Contact: Steve Binysh T: +44 (0)7940 565 478
E: info@actapharma.com 48 Grosvenor Gardens
Woodford Green
Essex
IG8 0BD
England
| Established in 2001, Acta Pharma Services provides professional, efficient and flexible consultancy services in regulatory affairs. Based in London, England it specialises in the preparation, filing and maintenance of marketing applications for the UK and EU. We will help you to meet your aims and deadlines cost effectively.
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| Akos Contact: Meera Vinay T: +44 (0) 1582 766339
E: meera.vinay@akos.co.uk The Coach House,
AKOS Ltd
Pipers Lane,
Harpenden,
Hertfordshire AL5 1AH,
United Kingdom
| Since 1986, AKOS has been a leading provider of Pharmacovigilance, QPPV and Regulatory Services to Pharmaceutical, Biotech, Generic, and Medical Device companies. AKOS provides Global or Regional service offering with offices in Harpenden, UK and Research Triangle Park, NC, USA.
MAKE AKOS YOUR REMEDY…
aκος , εος, to/,(aκέομαι): Cure, Remedy
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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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| Cristina Santos Regulatory Affairs Contact: Sara Cristina Santos T: +33 (0)1 77 69 64 22
E: cristinasantos@pharmabureau.com Head Office
Cristina Santos Regulatory Affairs
1, place Paul Verlaine
92100 - Boulogne Billancourt
France
Portugal
Cristina Santos Regulatory Affairs
Rua Correia Teles, 28 A
(CP 168)
1350-100 Lisboa
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.
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| Cyton Biosciences Ltd Contact: Stuart Thomas T: +44 (0) 117 973 9036
E: sthomas@cyton.com 2, St. Pauls Road
Clifton
Bristol
BS8 1LT
U.K
| 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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| Exova Contact: Carole Tidy T: +44(0) 161 787 3291
E: info@exova.com Prova Court
17, Doman Road
Camberley
Surrey
GU15 3DF
UK
| Exova have extensive experience working with MHRA and other Regulatory Authorities
and can help in the following key areas:
• Chemistry, Manufacturing and Control (CMC) and Module 3
• National and European Variations
• GAP analyses
• Quality Overall Summaries
• Scientific Report Writing for dossier submission
See pdf for further services.
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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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| Fukuma Advogados e Consultores Jurídicos Contact: Patricia Fukuma T: Tel.: +55 (11) 3083-3539
E: contato@fukumaadvogados.com.br Rua Gomes de Carvalho, 1069 - conj. 133 e 134
04547-004 - São Paulo/SP - Brasil
| Fukuma Advogados e Consultores Jurídicos is an attorneys’ office dedicated to providing services in the areas of Regulatory Law (drugs, food, health products and cosmetics); Legal Metrology; Consumer Rights defending companies of sanitary vigilance sector against consumer claims; Biosafety Legislation (Genetically Modified Organisms – GMOs), and; Agreements.
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| Fulcrum Pharma Contact: T: +44 (0) 118 989 5680
E: | | |
| ICON Global Regulatory Affairs Contact: T: +44 (0)1628 496300
E: info-clinical@iconplc.com UK Office:
ICON Clinical Research (UK) Ltd
2 Globeside
Globeside Business Park
Marlow
Buckinghamshire, SL7 1HZ
| Full Service Provider:
- Consulting and Operational Services throughout the product lifecycle
- Preparation, filing, pre- and post-submission services for Clinical Trials and Product Approvals
- Experienced personnel - EU, US and Global
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| 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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| Kompass Regulatory Services Ltd Contact: Barry Geoghegan T: 0906 66 34100.
E: rmcentire@kompassreg.com Ardsallagh Business Park,
Athlone Rd.,
Roscommon,
Ireland
| REGULATORY & CLINICAL SERVICES
Pharmaceuticals, Medical Devices & Combination Products
Electronic Common Technical Document (eCTD)
Clinical Trial Applications, IMPD, Bioequivalence studies, Investigator brochure, IND,
Clinical and non-clinical overviews & summaries
Licence registrations and maintenance in Europe & U.S- National, MRP, DCP, Centralised, CE marking, DMF, EDQM
Readability testing/PIL testing/mock-up creation, SmPC sourcing & harmonization
Product Quality Review Reports/Annual Reports
Controlled Substances licensing & Management
Due diligence, SOP preparation, Site Master File
& Auditing
Pharmacovigilance
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| Life Scientific Contact: T:
E: 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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| Pharma-EU s.r.o. Contact: Kurtis Kinsey T: 00 420 257 533 768
E: kurt@pharma-eu.com Malostranske Namesti 23
Prague 1
118 00
Czech Republic
| Expert European regulatory services ready to partner with your company.
• European procedure scheduling and coordination.
- CPs, DCPs or MRPs.
• Dossier GAP analysis and conversion to CTD.
• eCTD conversion and publishing using Extedo.
• Czech/Slovak market regulatory expertise from development to post marketing.
• Readability testing of Patient Information Leaflets (English, Czech, Polish, French, Spanish and Dutch).
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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: kotoole@pharmalinkconsulting.com Vandervell House
Vanwall Business Park
Maidenhead
Berkshire
SL6 4UB
| Pharmalink Consulting is the world’s largest independent Regulatory Affairs Consultancy.
We provide Regulatory Affairs support services to Healthcare companies globally.
Our Clients benefit from our top-quality interim Regulatory Affairs staffing solutions and Consultancy Services.
We have offices in the USA, UK, India and Singapore.
In addition, we have developed our our ‘PAN’ – a network of Regulatory Affairs consultants in over 100 countries to offer local assistance, advice and support to our clients who may be expanding to new and emerging markets.
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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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| 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: Natalie Grogan T: +44 (0)1209612650
E: info@tracservices.co.uk Pool Innovation Centre
Trevenson Road
Pool
Redruth
Cornwall
TR15 3PL
| 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.
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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: Dr Chris Wainwright T: +44 (0)1628 530554
E: enquiries@wainwrightassociates.co.uk Wessex House,
Marlow Road,
Bourne End,
Buckinghamshire,
SL8 5SP,
U.K.
| 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.
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