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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 60 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,   decentralised, mutual recognition and national procedures

Electronic (eCTD) submissions

Licence maintenance: variations, renewals, change of ownership, change of legal status

Orphan designation

Paediatric investigation plans

Scientific advice procedures

 

Appeals & Hearings

Re-examinations, Arbitration & Referrals

Guidance throughout the procedure
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

 

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, PIL & label 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 60 countries

 
Licensing

Searches for new products
Licensing negotiations
Evaluation of opportunities
Location of licensing partners
Technical/regulatory due diligence


 
 

Services: 

Contract Auditing, Drug Master File Dossiers, Electronic Submissions Preparation, Expert Reports, Licensing/Acquisitions, Medical Devices/Combination Products, Patient Information Leaflets (PIL)/ Labeling, Pharmacovigilance, Regulatory Affairs/Regulatory Strategy, Strategic Planning and Implementation

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 : Dr. Chris Wainwright