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Wainwright Associates Limited

Description: 

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 70 countries of the world.

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

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
Scientific consultancy
 
Regulatory Submissions
Presubmission meetings & liaison with authorities
Clinical trial authorisations & ethics submissions
Marketing authorisations via centralised, de-centralised, mutual recognition and national procedures
Electronic (eCTD) submissions
Licence maintenance: variations, renewals, change of ownership, change of legal status
Orphan designation
Paediatric investigation plans, deferrals & waivers
Scientific advice procedures
 
Appeals & Hearings
Re-examinations, Arbitration & Referrals
Preparation of written responses
Preparations for presentations
Rehearsals and mock appeals
Leadership in oral explanations
 
Medical Device Services
Classification & best route to market
CE Marking
Preparation of technical files, quality manuals & risk assessments
 
Audits
GCP, GMP, GLP, GDP
ISO 9001 & ISO 13485
Pharmacovigilance/device vigilance
 
Pharmacovigilance
Clinical study & post-marketing case processing
EU QPPV
PSURs,annual safety reports, SOPs
Strategic advice & inspection preparations
Medical Information & Scientific Advice
 
Technical Support in Litigation Cases
Advice to the legal profession on pharmaceutical, preclinical, clinical and regulatory issues
Location of suitable documents to form competent evidence
Expert witness
 
Product Literature
Writing SPC, label & leaflet texts and design of artwork
User testing
Advertising compliance
 
Global Regulatory Intelligence
Determination of regulatory requirements worldwide
Local support for national regulatory submissions
Local advisors in over 70 countries
 
Licensing
Searches for new products
Licensing negotiations
Evaluation of opportunities
Location of licensing partners
Technical/regulatory due diligence

Services: 

Diagnostic Test Evaluation, Electronic Submissions Preparation, GCP Compliance, GLP Compliance, GMP Compliance, Licensing/Acquisitions, Medical Devices/Combination Products, Pharmacovigilance, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation

Contact Information: 

Wainwright Associates Limited
Wessex House, Marlow Road
Bourne End, , SL8 5SP, GBR
Phone : 01628530554
Fax : 01628530559
Internet : www.wainwrightassociates.co.uk
Email : enquiries@wainwrightassociates.co.uk
Contact Person : Dr. Chris Wainwright