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Wainwright Associates Limited


Wainwright Associates are global experts in regulatory affairs, pharmacovigilance, licensing and product development. They have an extensive track record of working with SMEs and biotechs through to large multinationals within the pharmaceutical, medical device and healthcare industries. Providing advice and hands-on support throughout the product lifecycle, they enable clients to achieve competitive advantage as well as compliance in the regulatory environment.

Services cover all the specific activities listed below. We also provide training on all the listed topics.

Regulatory Submissions
Presubmission meetings & liaison with authorities
Clinical trial authorisations & ethics submissions
Marketing authorisations via centralised, decentralised, mutual recognition and national procedures
Electronic (eCTD) submissions
Licence maintenance: variations, Article 61(3) notifications, change of ownership, change of legal status
Orphan designation
Paediatric investigation plans, deferrals & waivers
Scientific advice procedures
Active substance master files
Environmental risk assessments
Post-approval commitments

Global Regulatory Intelligence
Determination of regulatory requirements worldwide
Local support for national regulatory submissions
Local advisors in over 70 countries
Literature searches

Clinical trial safety management
Clinical study & post-marketing case processing
Eudravigilance registration and reporting
PSURs, Annual safety reports,
Strategic advice & inspection preparations
Medical information & scientific service
Risk management plans
Pharmacovigilance System Master Files (PSMF)
Quality management systems

Marketing Authorisation
Searches for new products
Licensing negotiations
Evaluation of opportunities
Location of licensing partners
Technical/regulatory due diligence
Transfer of technology, including identification of contract manufacturers

Product Development Planning
Advice on applicable legislation
Recommendation of best route to market
Borderline issues addressed
Strategic regulatory planning of R&D programmes
Study design & protocol development
Pharmaceutical, non-clinical and clinical consultancy
Assessment of scientific documentation

Medical Device Services
Classification & best route to market
CE Marking
Preparation of technical files, quality manuals & risk assessments

Product Literature
Writing SMPC, label & leaflet texts and design of artwork
User testing
Promotional review and compliance

ISO 13485
Pharmacovigilance/device vigilance audits
Supplier audits


Contact Information: 

Wainwright Associates Limited
Wessex House, Marlow Road
Bourne End, , SL8 5SP, GBR
Phone : 1628530554
Fax : 1628530559
Internet : www.wainwrightassociates.co.uk
Email : enquiries@wainwrightassociates.co.uk
Contact Person : Jon Jeffery