TRAC Services Limited
Established in 2001, TRAC The Regulatory Affairs Consultancy is an award-winning, independent regulatory affairs consultancy dedicated to serving the global healthcare industry.
We are regarded as one of the leading EU regulatory affairs consultancies, working with a wide range of companies, from large multinational healthcare concerns to start-ups, providing project management, full regulatory management and advice on regulatory requirements and strategy.
Our teams commitment to quality and personalised service sees us enjoy high volumes of repeat business, something we are very proud of.
TRAC provides a full range of EU regulatory affairs consulting services to the pharmaceutical industry.
We cover all stages of the product lifecycle:
- Scientific Advice Meetings
- Clinical Trial Applications
- Marketing Authorisation Applications
- PIL Authoring, Testing and Bridging
- eCTD and NeeS Publishing & Submissions
- Variations and Renewals.
THE TRAC TEAM
Our regulatory affairs consultants knowledge covers every aspect of the pharmaceutical industry, and their work, and yours, is ably supported by our dedicated business and office team.
Our team of regulatory consultants provide support for clients in a number of different ways:
- On-going support with long-term projects
- Interim support to help with changes in workload or specific activities
- Managing the regulatory aspects of bespoke projects.
All of our team members have life science degrees and their individual regulatory areas that they specialise in. We also have our own worldwide database of experienced independent associates who provide flexible freelance support on client projects as needed.
At TRAC, we recognise that this knowledgeable and experienced team is our most valuable asset and we are committed to a continual programme of training and development that keeps everyone up to date with all things regulatory. Team members attend, participate in and lead courses and conferences and all our regulatory consultants are members of The Organisation for Professionals in Regulatory Affairs (TOPRA).
All projects are managed by a member of our senior team, who best fits your particular needs, to ensure that work is carried out effectively by the appropriate level of expertise.
HOW WE WORK
Our outstanding service comes from our expertise at applying our knowledge and experience to meet your specific business challenges.
We pride ourselves on being flexible and offering a bespoke service. Your dedicated regulatory affairs consultant will start off by taking the time to listen and fully understand your requirements and working preferences. We see establishing and agreeing a way forward as key to creating a successful working relationship.
Projects are managed through our professional service automation system (PSA). This allows us to monitor progress and plan resource and workload in line with key milestones, as well as keeping you regularly updated. We pride ourselves on being responsive and flexible. If your project changes we adapt.
We undertake a full review at the end of every project, something that sees us continuously improving the service our people and processes provide.
And it shows around 70% of our business comes from clients who choose to work with us again!
+44 (0)1209 612650
