Independent Regulatory Affairs Consulting

EU & UK product compliance, made clear.

Hands-on regulatory support for brands bringing food supplements, cosmetics and medical devices to European and British markets — from formula and claims to labels and safety files.

Food Supplements
Cosmetics
Medical Devices
EU / UK Market Access
Services

Regulatory work that gets products on shelf.

Practical, documented outputs your team, partners and authorities can rely on.

01

Food Supplements

Formulas, labels and claims aligned with EU and UK food law, ready for each target market.

  • Ingredient & novel food screening
  • Daily dose, NRV & nutrition data
  • Health claims & label review
  • DE · FR · IT · NL localisation
  • National notifications
02

Cosmetics

Safety documentation and label compliance under Regulation (EC) No 1223/2009 and UK rules.

  • CPSR Part A & B
  • Product Information File (PIF)
  • INCI, label & claims review
  • Raw material documentation
  • CPNP / SCPN coordination
03

Medical Devices

Documentation support that helps manufacturers close gaps before formal review.

  • Technical documentation gap review
  • Labelling & IFU consistency
  • ISO 13485 / 14971 related documents
  • Market-access assistance
EU / UK Market Access

One point of contact for the roles your product needs.

Non-EU and non-UK brands often need a local operator on the label. ComplyCrest coordinates these services through specialist partner entities, alongside the regulatory work — so documentation and responsibilities stay aligned.

RP

Responsible Person — Cosmetics

EU and GB Responsible Person services via partner entities.

FBO

Food Business Operator

EU operator arrangements for food supplements and foods.

AR

Authorised Representative

Representation for medical device manufacturers.

Selected Work

From non-compliant to market-ready.

A typical label remediation, simplified. Every change is traced to the applicable requirement and documented.

Before
Daily doseInconsistent with serving
%NRVCalculated on wrong basis
ClaimsNot on authorised list
WarningsIncomplete
LanguageEnglish only
→
After
Daily doseAligned with formula
%NRVRecalculated per EU values
ClaimsAuthorised wording only
WarningsMandatory statements added
LanguageTarget-market text supplied

Illustrative summary. Client artwork and data are not shown.

Powder supplement

Dose & claims correction

Daily dosage, %NRV and claims reworked to match the formula and authorised wording.

Botanical liquid

Four-language label

Formula reconciled to serving size; claims, warnings and EN/NL/DE/FR text aligned.

Mineral & mushroom

Ingredient identity review

Species naming, EU NRV values and daily dose checked across a product range.

Fruit powder

UK → German market

English artwork adapted for Germany: nutrition data, operator details and warnings.

About

Scientific depth, commercial focus.

ComplyCrest is an independent regulatory affairs consultancy built on a scientific foundation in biotechnology and translational medicine. We help brands from Europe, North America, Asia and Australia bring food, supplements and cosmetics to EU and UK shelves.

40+client projects in food, supplements & cosmetics
30+German BVL supplement notifications
10European markets: DE · FR · IT · ES · NL · BE · IE · LU · UK · CH
~10years of regulatory & scientific experience
Food supplementsFunctional foods & beveragesSports nutritionNovel food screeningHealth claims & NRVCPSR & PIFCPNP notificationsNail, skin & baby care

Why ComplyCrest

Specialist support, without the overhead

We combine scientific rigour with day-to-day regulatory delivery: cosmetic safety reports and PIFs, food supplement formula and label reviews, and medical device documentation.

Our clients get clear findings, practical solutions and documents they can act on.

  • Senior-level expertiseEvery project is handled by experienced regulatory specialists.
  • Specialist partner networkRP, FBO and AR services coordinated with trusted EU/UK partners.
  • Direct communicationNo account managers in between: fast, clear answers.
How we work

Simple, transparent process.

Intro call

Your products, target markets and timeline.

Scope & quote

A clear fixed scope before any work starts.

Review & deliver

Findings, corrected wording and documents.

Launch support

Partner coordination and follow-up questions.

Contact

Planning an EU or UK launch?

Tell us about your product and target market. We will come back with a clear next step.

Discuss your project → or email contact@complycrest.com