Wainwright Associates Ltd
Wessex HouseMarlow Road
Bourne End
SL8 5SP (Road Map)
Tel: 01628 530554
Fax: 01628 530559
Number of Employees: Unavailable
www.wainwrightassociates.co.uk
admin
wainwrightassociates.co.uk
Wainwright Associates Limited are consultants in product development, regulatory affairs and licensing
- Regulatory affairs
- Pharmaceutical consultancy
- Electronic submissions (eCTD)
- User readability testing
- Appeals and hearings
- Pharmacovigilance
- Quality audits
- Licensing
Regulatory affairs services include advising on regulatory strategy and planning, scientific consultancy and data assessment, user/readability testing, preparation, submission and maintenance of clinical trial and marketing authorisation applications including eCTD. Its speciality is in appeals and hearings with a success rate in excess of 90%.
Based in Europe it can advise on the harmonised EU requirements for medicinal products, medical devices, herbals, and nutritional products. The company also provides a search facility for new products, licensing partners and manufacturers. Other services include pharmacovigilance, GMP/quality audits, design of in-house seminars and technical support to the legal profession in litigation cases.
Most regulatory affairs consultancy services can be offered within our experienced team.
Products and Services
- Appeals and Hearings
- Audits - Pharmacovigilance
- CE Marking Services
- Clincal - Consultancy
- Clinical Development Planning
- Clinical Trial Authorisation Applications
- Consultancy - Pharmacovigilance
- Consultancy - Preclinical
- Consultants - Clinical
- Consultants - Medical
- Consultants - Medical Devices
- Consultants - Regulatory
- Consultants - Regulatory, Advice
- Expert Witness - Pharmaceuticals
- Licensing
- Marketing Authorisation Applications
- Medical - Consultancy
- Patient Information Leaflet - Testing
- Patient Leaflets - Readability Testing
- Pharmaceutical - Consultancy
- Pharmaceutical - Services
- Pharmaceutical - Specialists
- Pharmaceuticals
- Pharmacovigilance
- PIL - Testing
- PIL - User Testing
- Publishing - eCTD
- Qualified Person for Pharmacovigilance (QPPV)
- Readability Testing
- Regulatory Affairs - Appeals and Hearings
- Regulatory Affairs - Clinical Trial Authorisations, CTAS
- Regulatory Affairs - Consultancy
- Regulatory Affairs - Consultants
- Regulatory Affairs - Contracts
- Regulatory Affairs - Desk Research
- Regulatory Affairs - ECTD
- Regulatory Affairs - Marketing Authorisation Applications, MAA
- Regulatory Affairs - Medical
- Regulatory Affairs - Medical Devices
- Regulatory Affairs - On Site Placements
- Regulatory Affairs - Pharmaceutical
- Regulatory Affairs - Specialists
- Regulatory Affairs - Support
- Regulatory Affairs - Vacancies
- Regulatory Interim Management
- Regulatory Strategy
- Regulatory Submissions
- Safety Reporting
- Training - Pharmaceutical
- User Readability Testing
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