Regulatory Affairs

How Can A Regulatory Affairs Consultant Help?

Bringing a food supplement, medical device, or cosmetic to market requires navigating complex regulations, so you need regulatory affairs consultants on your side that know their stuff.

At Taylored Consultancy Ltd, we simplify the compliance process for you and your team, ensuring your product meets all UK and EU regulatory requirements and is ready to go to market.

We handle everything from Product Information File(PIF) preparation and label compliance to safety assessments and market approvals, so you can focus on what matters most; growing your business.

Whether you need a UK Responsible Person (UKRP),an EU Authorised Representative (EC-REP), or expert guidance on regulatory documentation, we provide no-nonsense, tailored support to get your product launch-ready—quickly and compliantly

Regulatory documentation is the cornerstone of compliance

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.

How DO WE WORK

Streamlined Solutions, Step by Step

We’ve helped brands navigate competitor challenges, supported companies under MHRA scrutiny, and stepped in when businesses needed urgent regulatory intervention to stay on the market.

We’re known for helping innovative brands push boundaries, working with businesses launching cutting-edge, first-of-their-kind products that challenge the status quo.

Our expertise covers everything from Product Information Files (PIFs), UK Responsible Person (UKRP) and EU Authorised Representative (EC- REP) services, safety assessments, labelling compliance, and ongoing regulatory maintenance.

Whether you need a one-off consultation or long-term strategic support, we tailor our approach to fit your needs, timelines, and budgets.

Looking for a regulatory partner who understands business? Let’s talk.

Testimonials

Our happy clients say about us

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Bethany has a wealth of experience in medical devices and is always providing a fantastic service. Having worked with Bethany on and off over the years I can safely say I would trust her regulatory advice. Thank you Taylored & the team!

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The Cosmetic Regulator
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We have been working with Bethany for 3 months now and are very impressed! She is super orgainsed, very knowledgable and does it all with a smile! Would highly recommend.

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George Kruis
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Amazing! Went over and above working longer hours communicating with suppliers and getting all the relevant info. Quick to find solutions and overall very helpful. Thank you!

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Tom Attwood
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