Regulatory Affairs
Your Regulatory Expertise And Compliance Experts for Medical Devices, Cosmetics, and Food Supplements.
How Can A Regulatory Affairs Consultant Help?
Regulatory Affairs Consultants play a crucial role in ensuring that products such as medical devices, cosmetics, and food supplements comply with all relevant government regulations and standards.
At Taylored Consultancy, we provide regulatory expertise to product development teams, scientists, and senior management teams to ensure safety and compliance before, during, and after product launch.
Our role is to help you prepare and submit your regulatory documentation and maintaining your files and technical documentation going forwards.
Regulatory documentation is the cornerstone of compliance
Key Aspects of Regulatory Documentation
Preparation and Submission
Regulatory documentation involves meticulous preparation and submission of various forms and reports to regulatory agencies like the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This includes compiling data from clinical trials, laboratory tests, and manufacturing processes to demonstrate that the product meets all regulatory requirements.
Maintenance
Once submitted, regulatory documentation must be maintained accurately and up-to-date. This includes updating records with any new information, changes in manufacturing processes, or additional safety data. Proper maintenance ensures that the regulatory files reflect the current status of the product and are readily available for review during inspections or audits.
Document Management
We manage your regulatory documentation and technical files on an ongoing basis to make sure that your products remain compliant with the country in which they are being distributed. We track and monitor submission deadlines, renewal dates, and compliance status to stay within the regulatory guidelines throughout the products lifespan.
Types of Regulatory Documentation
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Your technical documents include detailed information on the product’s design, manufacturing process, and quality controls. For medical devices, for example, the technical file must provide evidence that the device meets the essential requirements set out in the relevant regulations.
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Clinical trial reports demonstrate the safety and efficacy of a product based on rigorous testing.
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Your Declaration of Conformity is a formal statement declaring that the product complies with all relevant regulations and standards.
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These include various applications and forms submitted to regulatory bodies, such as UK MHRA and US FDA. Submissions must be meticulously prepared to meet the format and content requirements specified by the relevant regulatory authority.
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Our work doesn't end when a product has launched. After a product is on the market, ongoing monitoring and reporting of its performance and any adverse events is essential.
Why Choose Taylored Consultancy?
We don’t just claim innovation; we show it
At Taylored Consultancy, we develop and deliver bespoke solutions, allowing you to introduce your product into your chosen market. We adopt a forward-thinking approach to make sure that all projects are geared towards the future and support the growth of your business.
Our coordinated methodology keeps you aligned and our team delivers expert advice to meet your regulatory needs staying up to date with regulations and offering insights into upcoming changes or updates.
We collaborate with you as an integral part of your team
We work closely with your organisation to guarantee our solutions are incorporated across all departments.
What Our Clients Say
I am writing to wholeheartedly recommend Bethany, whose collaboration has not only been immensely valuable but truly transformative in our recent project. Bethany stands out as a beacon of professionalism, demonstrating a level of dedication and expertise that is rare and highly commendable. Her dynamic approach to challenges is both refreshing and effective, allowing our team to navigate complexities with confidence. Bethany possesses a unique ability to anticipate the needs of a project, taking informed, proactive steps that ensure success. This foresight, combined with her willingness to take initiative in key decision-making processes, has significantly contributed to our achievements. I highly recommend Bethany, without hesitation!
Sven, Managing Director
Taylored Consultancy were clear with direction, great at communicating, and easy to get in contact with.
Jan, Director
Working with Taylored Consultancy has brought an additional layer of expertise to our business. Collaborating with Bethany has allowed us to remain compliant, whilst offering practical solutions that help us to clearly and effectively communicate with our customers. From formulations through to consumer-facing claims, Bethany remains a joy to work with, always on hand to expertly offer tailored regulatory advice.
Heather, Head of Marketing
Ready to take the next step?
Get in touch today to learn how Taylored Consultancy can help you achieve regulatory compliance and market success.