About Us
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.
Additional services
• Strategic planning from early product development
• Regulatory submissions and publishing (eCTD)
• Pharmacovigilance and EU QPPV
• Appeals and Hearings
• Licensing and “due diligence”
• Local advisors in over 60 countries
• Package leaflet user testing
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.
Expertise
• Regulatory affairs
• Pharmaceutical
• Preclinical
• Clinical
• Linguistics
How to find us
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Featured Services
Wainwright Associates Ltd have 53 services listed - these are some of their top services.
Our data assessment services facilitate regulatory approvals by identifying potential deficiencies, ...
We provide a full range of services for companies working with medicinal products, whether from a ph...
A full range of consultancy services relating to medicines is available. These are applicable to all...
Our clinical consultancy services include many areas of clinical research, such as Clinical Trial Au...
Once the trial is completed, if required, we will be happy to write the clinical study report. We ca...
All kinds of regulatory submission are handled by Wainwright Associates, including Clinical Trial Ap...
Under the Clinical Trial Directive 2001/20, authorisation by a Competent Authority is required to co...
Sponsors need to satisfy themselves that a CRO is capable of conducting a clinical trial to the appr...
Our global regulatory intelligence service can identify and advise on local regulations and provide ...
We can help with both in-licensing and out-licensing. Our consultants can begin with a search for li...
Product development services include strategic regulatory planning, assessment of scientific data an...
From early product development, our team of consultants can guide you to a regulatory pathway that w...
Our team of highly experienced regulatory affairs consultants can help you, whether it involves:
...
Our consultancy services will help you through your regulatory submissions from presubmission planni...
We provide a full range of services for companies working with medicinal products, whether from a ph...
All kinds of regulatory submission are handled by Wainwright Associates, including Clinical Trial Ap...
We offer a full range of consultancy services relating to medical devices and in vitro diagnostics
...
Meeting your post-marketing pharmacovigilance, clinical study safety, or device vigilance obligation...
Medical device registration in the European Union is harmonised with three directives now in force:
...
Wainwright Associates Limited offers wide-ranging consultancy services relating to medical devices a...
Wainwright Associates can assist with setup and operation of your medical device vigilance procedure...
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Featured News
Wainwright Associates Ltd have 45 news listed - these are some of their latest news.
The Prescription Medicines Code of Practice Authority (PMCPA) that is responsible for administering ...
The European Medicines Agency has recently published a guide on regulatory procedural advice on simi...
The Roles and Responsibilities of an EEA Qualified Person for Pharmacovigilance (QPPV)
This webin...
Following a successful pilot, the European Medicines Agency (EMA) has announced that its eSubmission...
Dated 16 April 2012, the European Commission has issued the Draft Template for the Written Confirmat...
The European Medicines Agency has invited marketing-authorisation holders and other stakeholders to ...
The MHRA has announced procedural changes concerning the requirement to submit full-colour mock-ups ...
Orphan Medicinal Products in the EU: Eligibility, Orphan Designation and Incentives
The structure...
The Heads of Medicines Agencies(HMA) and the European Medicines Agency (EMA) have adopted a joint gu...
An updated set of mandatory requirements for Marketing Authorisation Holders (MAH) to comply with Ar...
The European Medicines Agency has now released drafts of the first seven Good Pharmacovigilance Prac...
The European Medicines Agency has now released drafts of the first seven Good Pharmacovigilance Prac...
Following the recommendations on transparency published by the European Heads of Medicines Agencies ...
The Regulatory Authority Pharmacovigilance Inspections webinar is designed to inform anyone who is i...
The European Medicines Agency has released an implementation plan for the pharmacovigilance legislat...
The European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) have agreed to wor...
The European Mutual Recognition and Decentralised Procedures - Introduction and Comparison:
This...
In accordance with the provisions of the new pharmacovigilance legislation, as per Directive 2010/84...
Changes are being made in the way fees are paid for regulatory submissions and procedures in France....
Due to their popularity, Wainwright Associates are repeating the Pharmacovigilance and regulatory af...
A new version of the MHRA pharmacovigilance Compliance Report (Good Pharmacovigilance Practice Quest...
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Featured Jobs
Wainwright Associates Ltd have 1 jobs listed - these are some of their latest jobs.
Wainwright Associates are looking for a Regulatory Affairs professional with a minimum qualification...