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Design Quality Consulting helps organisations turn Quality, Regulatory and Environmental Compliance into a strategic business advantage.
We work with leaders who value clarity, credibility and measurable results.
Stabilise → Optimise → Standardise → Scale
Clarity - Structure - Results
About the Company
How Can We Help
Regulatory & Compliance
Trusted by leaders navigating complexity, regulation and change.
About the Company
About the Company
Design Quality Consulting is a boutique advisory firm specialising in Quality, Regulatory Compliance, environmental regulations, and organisational excellence for companies operating in highly regulated environments across Europe (including the UK) and North America.
The firm is founded and led by a senior quality executive with over 20 years of international experience across Pharma, OTC, FMCG, cosmetics, food & beverages, personal care (including baby care), and manufacturing sectors.
We support organisations in designing, stabilising and optimising Quality Management Systems, environmental and compliance frameworks, including preparation for ISO 9001, ISO 14001, GMP and ISO 22716 audits, as well as customer audits.
We conduct targeted internal audits across selected areas of the organisation, identifying key risks and non-conformities, and developing realistic CAPA plans to support effective implementation.
Our approach is grounded in a deep understanding of audits and regulatory requirements, supported by hands-on auditing experience and practical application of ISO 9001 and ISO 14001 standards at both implementation and operational levels, as well as experience working within complex, global supply chains.
We act as an independent advisory partner, supporting organisations in audit, inspection and certification readiness, without performing certification or regulatory authority activities.
We help organisations move beyond reactive compliance and build robust, defensible and scalable systems that support both regulatory expectations and long-term business performance.
How Can We Help
How Can We Help
We help organisations design, stabilise and optimise Quality, Regulatory and Sustainability systems that work in real operating environments, not only on paper. Our support spans the full maturity journey, from addressing critical compliance gaps to building scalable, audit-ready governance models, and includes:
QMS Assessment, Risk Analysis & Transformation Readiness
QMS Assessment, Risk Analysis & Transformation Readiness
Independent assessment of the current Quality Management System (QMS), including governance, processes, documentation and operational effectiveness. We provide:
structured QMS maturity and gap analysis
risk-based assessment aligned with regulatory and business priorities
identification of systemic weaknesses and compliance exposure
clear improvement steps and prioritised roadmap
preparation for QMS optimisation or full transformation programmes. This approach enables informed decision-making, focused investment and controlled change.
Quality Management Systems & ISO Certification Support
Quality Management Systems & ISO Certification Support
Design, optimisation and integration of ISO-based and sector-specific quality systems, including ISO 9001 (Quality Management Systems), ISO 14001, ISO 22716 (Cosmetics GMP) and aligned Pharma GMP / GDP frameworks. We provide end-to-end support for ISO 9001 certification, including:
readiness assessments and gap analysis
QMS design and documentation
implementation support and team coaching
internal audit and management review preparation
certification audit readiness and post-audit improvement
Regulatory, GMP & Audit Readiness
Regulatory, GMP & Audit Readiness
Expert support in Pharma and Cosmetics regulatory compliance, including participation in and leadership of corporate and third-party audits. We support EU GMP, GDP and ISO 22716 audit readiness, findings remediation, CAPA governance and the design of oversight models that withstand regulatory and customer scrutiny.
Supplier Oversight & Risk-Based Compliance
Supplier Oversight & Risk-Based Compliance
Design of risk-based supplier qualification, audit planning and ongoing oversight frameworks across global supply chains. Our approach ensures clear accountability, defensible decision-making and effective governance, particularly critical for shared audits and complex supplier networks.
Continuous Improvement & Operational Excellence
Continuous Improvement & Operational Excellence
Practical implementation of Lean - Six Sigma and Agile methodologies to strengthen cross-functional collaboration, eliminate waste and deliver measurable improvement, including reductions in Cost of Poor Quality (COPQ).
Sustainability & Packaging Compliance
Sustainability & Packaging Compliance
Advisory support in sustainable packaging, product stewardship and regulatory alignment, including EPR and PPWR readiness, eco-design and environmental compliance aligned with evolving EU sustainability requirements.
Regulatory & Compliance
Regulatory & Compliance
Our advisory work covers both EU and US regulatory frameworks. While EU Directives and Regulations are jurisdiction-specific, our expertise extends to equivalent US requirements, including FDA cGMP, MoCRA, ISO-based management systems, and globally recognised audit and testing standards.
Key EU Legal Frameworks
General Product Safety & Market Surveillance
General Product Safety Regulation (EU) 2023/988 (GPSR)
https://eur-lex.europa.eu/eli/reg/2023/988/oj
Market Surveillance Regulation (EU) 2019/1020
https://eur-lex.europa.eu/eli/reg/2019/1020/oj
Pharma & OTC
Directive 2001/83/EC – Community code relating to medicinal products for human use
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32001L0083
EU Guidelines for Good Manufacturing Practice (EudraLex Volume 4)
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
Good Distribution Practice (GDP) Guidelines (2013/C 343/01)
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013XC1123(01)
Cosmetics & Personal Care
Cosmetics Regulation (EC) No 1223/2009
https://eur-lex.europa.eu/eli/reg/2009/1223/oj
ISO 22716 – Cosmetics GMP (reference standard)
https://www.iso.org/standard/36437.html
(ISO standard – informational link, not EU law)
Safety Assessment & CPNP Portal (European Commission)
https://single-market-economy.ec.europa.eu/sectors/cosmetics_en
Quality, Environment & OHS (Management Systems – Legal Context)
(ISO standards themselves are voluntary, but widely recognised by EU regulators)
ISO 9001 – Quality Management Systems
https://www.iso.org/standard/62085.html
ISO 14001 – Environmental Management Systems
https://www.iso.org/standard/60857.html
Framework Directive 89/391/EEC – Occupational Safety and Health
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31989L0391
Packaging, Sustainability & Environmental Compliance
Packaging and Packaging Waste Regulation (PPWR – proposed / adopted text)
https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste_en
Extended Producer Responsibility (EPR) – EU Waste Framework Directive 2008/98/EC
https://eur-lex.europa.eu/eli/dir/2008/98/oj
Single-Use Plastics Directive (EU) 2019/904
https://eur-lex.europa.eu/eli/dir/2019/904/oj
REACH Regulation (EC) No 1907/2006
https://eur-lex.europa.eu/eli/reg/2006/1907/oj
CLP Regulation (EC) No 1272/2008
https://eur-lex.europa.eu/eli/reg/2008/1272/oj
Corporate Sustainability & Due Diligence
Corporate Sustainability Reporting Directive (CSRD) – Directive (EU) 2022/2464
https://eur-lex.europa.eu/eli/dir/2022/2464/oj
Corporate Sustainability Due Diligence Directive (CSDDD)
https://commission.europa.eu/business-economy-euro/company-reporting-and-auditing/company-reporting/corporate-sustainability-due-diligence_en
Product & Packaging Testing (Industry Standards)
(Non-legislative but commonly expected)
ISTA – International Safe Transit Association
https://ista.org
ASTM Standards (Packaging & Distribution Testing)
https://www.astm.org
Applicable /Equivalent in the US
Pharma & OTC (USA)
FDA – 21 CFR Parts 210 & 211 (cGMP for Finished Pharmaceuticals)
--> equivalent of EU GMP (EudraLex Vol. 4)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
21 CFR Part 820 – Quality System Regulation (QSR)
(device / combination products)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
FDA Inspections & Compliance Programs
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations
Cosmetics & Personal Care (USA)
MoCRA – Modernization of Cosmetics Regulation Act (2022)
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022
FDA Cosmetics Regulations
https://www.fda.gov/cosmetics/cosmetics-laws-regulations
ISO 22716 – Cosmetics GMP - voluntary, not federal law
https://www.iso.org/standard/36437.html
Quality Management Systems (Global / US)
ISO 9001 – Quality Management Systems
https://www.iso.org/standard/62085.html
ISO 14001 – Environmental Management Systems
https://www.iso.org/standard/60857.html
Product Safety & Consumer Products (USA)
CPSC – Consumer Product Safety Commission
https://www.cpsc.gov
Consumer Product Safety Act (CPSA)
https://www.cpsc.gov/Regulations-Laws--Standards/Statutes/The-Consumer-Product-Safety-Act
--> equivalent to the EU GPSR, but a different supervisory structure.
Packaging, Distribution & Testing (Global / US)
ISTA standards
https://ista.org
ASTM standards
https://www.astm.org
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