About Us
At Taylored Consultancy Ltd, we take the complexity out of regulatory compliance. Whether you’re launching a food supplement, medical device, or osmetic, we provide end-to-end regulatory support, from initial classification to market approval, so you can focus on growing your business.
Unlike a lot of regulators, we don’t just tell you what you can’t do.
We take a commercially minded approach, working with you to find practical, business-friendly solutions that ensure compliance without unnecessary delays or roadblocks.
80+ years of combined experiences
End-to-end regulatory and quality support - from label to launch, and everywhere after
Taylored Consultancy supports brands and manufacturers across cosmetics, food supplements, medical devices, software as a medical device (SaMD), in vitro diagnostics (IVD) and quality management - in the UK, EU, US, Australia, UAE and worldwide. Whether you're bringing your first product to market or expanding into new regions, we make compliance clear, practical, and stress-free.
We build tailored regulatory roadmaps that align with your commercial goals - helping you launch, expand, and stay compliant across multiple markets. Where reliance and recognition routes exist, we use them so an approval in one region helps open doors in others.
We review your labelling and packaging against each market's mandatory requirements - including language, warnings, ingredient lists and Unique Device Identifiers (UDI) - so nothing holds up your launch.
Cosmetic or medical device? Food or medicine? Class I or Class III? We determine exactly how your product is classified under each market's rules, so you follow the right pathway from day one.
From Cosmetic Product Safety Reports (CPSR) and biocompatibility testing to clinical evaluation and diagnostic performance data, we help you build the safety and performance evidence your products need.
We act as your UK Responsible Person (UKRP) and EU Authorised Representative (EC-REP), and help you appoint a US Agent, Australian Sponsor or UAE Local Authorised Representative - the local presence almost every market requires of overseas manufacturers.
We design, implement and improve quality management systems, from device-specific ISO 13485 to general ISO 9001, setting you up for certification and long-term compliance success.
From EUDAMED and the UK's SCPN to FDA listing, the ARTG and DM registration, we handle the regulatory paperwork so your product is correctly registered and notified before it enters the market.
Internal audits, supplier audits, gap analyses and pre-audit health checks -delivered by experienced lead auditors to keep you inspection-ready and help you avoid costly mistakes before they happen.
We build, audit and strengthen technical files, Clinical Evaluation Reports(CERs), General Safety and Performance Requirements (GSPR), performance evaluations and safety reports - so they hold up to regulator and Notified Body and authority scrutiny.
We guide software and AI-enabled products through qualification, classification, software lifecycle (IEC 62304), risk management and the evolving expectations around medical AI.
Our expert team reviews your formulation against the relevant UK, EU and international rules to confirm ingredient safety, legal compliance and market readiness - flagging restricted or prohibited substances before they become a problem.
Compliance doesn't stop at launch. We help you meet ongoing post-market surveillance, vigilance and reporting obligations so you stay compliant and confidently on the market.
Compliance doesn't stop at launch. We help you meet ongoing post-market surveillance, vigilance and reporting obligations so you stay compliant and confidently on the market.
More than market entry - we keep you compliant, in control and confidently on the market, with responsive expert support and practical team training at every step.
We’re not your typical consultants. We bring a unique blend of:
Helping you win in the marketplace, not just adhere to rules.
Deep, hands-on knowledge across cosmetics, supplements, and medical devices.
Compliance can be enjoyable - let’s make it so.
We’re clear, timely, transparent, and deliver what we promise.
