Regulatory Intelligence & Strategy

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ServiceDescriptionFurther Information
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.

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.

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).

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.

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.

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

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.