Product Development

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ServiceDescriptionFurther Information
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.

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).

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.

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.

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.

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.

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.