Regulatory & Quality Consulting
We guide you through regulatory and quality requirements – from strategy to audit-ready documentation.
Confident through complex regulation
Whether medical device, cosmetics, food or food supplement – we know the relevant standards and regulations and translate them into a clear, actionable plan.
You save time, avoid mistakes and enter audits and approvals with robust documentation.
- Regulatory strategy & gap analysis
- Technical documentation
- Audit & inspection preparation
Bring your product to market in full regulatory compliance
We take care of the regulatory side for you – from the initial classification to audit-ready documentation. You focus on your product; we make sure it is compliant, substantiated and marketable.
We also introduce products from abroad into the EU in full regulatory compliance: we review formulations, labelling and documentation against European law, close any gaps and make your product ready for import.
- Regulatory categorisation & classification
- Import & conformity of foreign products in the EU
- Labelling, formulation & documentation check
- Audit-ready documentation for authorities & trade
How we support you
From regulatory strategy through testing and studies to audit-ready documentation – an end-to-end service package for compliant products.
Regulatory strategy
Categorisation, classification and a roadmap for your compliant market access – including robust recommendations for every product type.
Technical documentation
Preparation and review of technical files, PIF/CPSR, assessment reports and proof of conformity – compiled to be review- and audit-ready.
Food & supplement testing
Testing of foods and food supplements – analytical assurance of ingredients, purity and specifications.
Conformity assessments
Assessment of your products against the applicable regulations and standards – with a clear conformity statement and recommended actions.
Safety studies
Design and management of safety studies – robust data as the basis for assessment, approval and market access.
Health claims review
Review of health and nutrition claims under Reg. (EC) 1924/2006 – formulate permissible claims reliably and in full legal compliance.
Audit preparation
Preparation for audits and inspections, including gap analysis, action plan and support through to audit readiness.
Market access EU & international
Requirements by target market – from EU conformity through import to international marketing.
Robust data as the foundation of your compliance
Compliance needs evidence. We combine regulatory consulting with testing and studies on foods, food supplements and products – creating an end-to-end chain of evidence from analysis to assessment.
This way, your documentation is not only formally complete but also substantively assured – the best basis for authorities, audits and trade.
- Food & supplement testing
- Testing of food & supplements to specification
- Safety studies & conformity assessments
- Linking analysis and regulatory affairs
Formulate health-related claims with legal certainty
Advertising claims for foods and food supplements are strictly regulated. We review your claims under the Health Claims Regulation Reg. (EC) 1924/2006 and show you what you may say – and how.
Claim review
Comparison of your claims with the EU list of permitted health claims and the nutrition claims.
Formulation & wording
Compliant rewording of critical claims, so that your marketing stays permissible and persuasive.
Evidence & substantiation
Compilation of the required evidence and substantiation for the claims used.
How we work
A structured path – from the status quo to audit-ready documentation.
1 · Categorisation
We analyse the product, target market and status quo and determine the applicable regulatory framework.
2 · Gap analysis
We identify gaps in formulation, testing, labelling and documentation and prioritise the necessary actions.
3 · Testing & evidence
We arrange the required tests, studies and assessments and prepare the necessary documentation of evidence.
4 · Documentation
We compile the audit-ready file – ready for authorities, audits, import and trade.
Regulation without detours
We review your status quo and show you the fastest compliant route to market.
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