COMBINATION PRODUCTS AND MEDICAL DEVICES CONSULTING LTD

What COMBINATION PRODUCTS AND MEDICAL DEVICES CONSULTING LTD does

Combination Products and Medical Devices Consulting Ltd (CPMD) is a UK-based specialist advisory firm founded in January 2026 by Abha Raveau-Violette, a former senior regulatory and operations leader with 17+ years of experience across AstraZeneca, Sandoz, and Teva. The firm provides regulatory strategy, quality and technical, and commercial consulting services to pharmaceutical and medical device organisations developing combination products — products that integrate drug, device, and biologic components and therefore require coordinated compliance with pharmaceutical and medical device regulatory regimes (e.g., FDA, EU MDR, ISO 13485, 21 CFR Part 4, GMP).

CPMD delivers its services through a structured service portfolio organised around a proprietary "Three-Pillar Operating Model" that integrates (1) Regulatory Innovation, (2) Quality & Technical Excellence, and (3) Commercial Readiness & Lifecycle Management, supported by a Training & Executive Coaching practice. Service offerings include regulatory strategy and foresight, FDA interactions, Notified Body Opinion preparation, design controls and design history file development, harmonised QMS architecture, supplier and manufacturing governance, remediation, bridging packages, and bespoke simulation-based learning. The methodology is applied through a Diagnose-Design-Deliver engagement process.

The firm operates as a professional services consultancy on a sales-led, consultative go-to-market model. Prospects are invited via the website to "request an initial discussion," after which bespoke engagements are scoped. No pricing is publicly disclosed; engagements are custom and described as multi-year in nature. The company is registered in England and Wales (Company No. 16938353), headquartered at 71-75 Shelton Street, Covent Garden, London, and claims service delivery to clients across the US, EU, and broader global markets. Revenue derives from project-based consulting fees and training/coaching programs, and the firm is privately held with no disclosed institutional investment.

Name

COMBINATION PRODUCTS AND MEDICAL DEVICES CONSULTING LTD

Legal name

Combination Products and Medical Devices Consulting Ltd.

Website

https://cpmd.co.uk

Company type

Private

Founded year

2026

Operating status

Operating

Short description

CPMD is a London-based specialist consultancy founded in 2026 that advises pharmaceutical and medical device organisations on regulatory strategy, quality systems, and commercial readiness for combination products, delivered via a proprietary Three-Pillar Operating Model.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

Keywords

• Regulatory affairs consulting
• Combination products consulting
• Medical device compliance
• Quality management systems
• Design controls consulting

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Regulatory and Technical Consulting Services: CPMD generates revenue through professional consulting engagements providing regulatory strategy, design controls, quality systems, and technical leadership services to pharmaceutical and medical device organisations. Services include remediation, bridging packages, FDA interactions, Notified Body Opinion preparation, and regulatory submissions.
2. Training and Executive Coaching: Revenue is generated through structured training programs including executive masterclasses, specialist deep-dive training, alignment workshops, coaching programs, capability academies, and bespoke simulation-based learning for regulatory, quality, and technical teams.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

CPMD is a specialist advisory firm that provides regulatory, quality, and commercial consulting services for pharmaceutical and medical device organisations developing combination products. Engagements cover regulatory strategy and FDA interactions, Notified Body Opinion packages, design controls and Design History Files, harmonised QMS architecture (GMP + ISO 13485 / 21 CFR 820), device master records, remediation, bridging packages, change management, and lifecycle management. The firm delivers these services through a proprietary Three-Pillar Operating Model that joins regulatory strategy, quality and technical excellence, and commercial readiness, supported by structured training and executive coaching programs.

Product overview

CPMD offers expert consulting services as a unified service portfolio, not a software product. The core offering is Combination Products Consulting Services, which encompasses four integrated service lines: Regulatory Innovation (regulatory foresight, integrated regulatory-technical alignment, documentation excellence), Quality & Technical Excellence (design controls, QMS architecture, supplier governance), Commercial Readiness & Lifecycle Management (market entry, value proposition, lifecycle cost management), and Training & Executive Coaching. These services are underpinned by the Three-Pillar Operating Model framework that connects regulatory strategy, quality/technical excellence, and commercial readiness to support efficient approvals and reduce risk across the product lifecycle.

Differentiator

Problem solved

Functional benefit

Products and services

• Combination Products Consulting Services Core consulting service for pharmaceutical and medical device organisations navigating the regulatory and technical complexities of combination products, delivered through a Three-Pillar Operating Model that connects regulatory strategy, quality and technical excellence, and commercial readiness.
• Regulatory Innovation Regulatory strategy and innovation services including Regulatory Foresight & Scenario Planning, Integrated Regulatory-Technical Alignment (DHF-CTD-QMS), Lifecycle-Ready Regulatory Systems, and Documentation Excellence, designed to transform regulatory complexity into competitive advantage for combination product sponsors.
• Quality & Technical Excellence Quality and technical consulting including Design Control Maturity Development, Harmonised QMS Architecture (GMP + ISO 13485/21 CFR 820), Supplier & Manufacturing Governance, and Post-Market Technical Resilience, intended to elevate design controls, quality systems, and technical documentation as strategic assets.
• Commercial Readiness & Lifecycle Management Commercial readiness and lifecycle consulting including Commercial-Regulatory-Technical Alignment, Accelerated Market Entry Programs, Value Proposition Strengthening, and Lifecycle Cost & Risk Management, focused on ensuring combination products are not only approved but commercially resilient.
• Training & Executive Coaching Structured training and coaching programs including Executive Masterclasses, Specialist Deep-Dive Training, Cross-Functional Alignment Workshops, Coaching Programs, Capability Building Academies, and Bespoke Simulation-Based Learning to build leadership and capability across regulatory, technical, and commercial functions.
• Three-Pillar Operating Model Proprietary advisory framework integrating Regulatory Strategy & Innovation, Quality & Technical Excellence, and Commercial Readiness & Lifecycle Management, delivered through a Diagnose-Design-Deliver process to support efficient approvals, reduce risk, and strengthen decision-making across the combination product lifecycle.

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• BioNowminorOthersCPMD is a proud member of BioNow, a UK-based organisation supporting the bioscience and life sciences ecosystem. BioNow membership provides CPMD with visibility within the biotech and medical technology community, positioning the firm as a specialist advisor in combination products and medical devices.

Scale indicators2 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• ICON plc: Global CRO offering regulatory and medical device consulting services as part of a broader clinical and commercial portfolio — competes with CPMD on enterprise regulatory mandates.
• NSF International (Health Sciences): Global organisation providing medical device regulatory consulting, training, and ISO 13485 certification services — a broader incumbent competitor in regulatory and quality advisory.
• IQVIA: Global life sciences services firm providing regulatory consulting, clinical, and commercial services to pharma and device manufacturers — a broad incumbent competitor with overlapping capabilities.
• Parexel International: Large global CRO with regulatory affairs and medical device consulting practices, offering broader scale and established client relationships across pharma and device manufacturers.

Direct peers

• Maetrics: Life sciences regulatory and quality compliance consultancy with strong medical device and combination product practices, serving pharma and device clients globally — directly comparable in scope and customer base.
• Qserve Group: Specialist regulatory and quality consulting firm focused on medical devices and combination products, with deep expertise in EU MDR, Notified Body processes, and ISO 13485 — directly overlapping with CPMD's core offering.
• Brandwood Biomedical (now part of RQM+): Specialist medical device regulatory consultancy historically focused on EU and FDA combination product submissions — a directly comparable niche peer.
• RQM+: Medical device and combination product regulatory/quality consultancy providing design controls, QMS, and submission support — a closely comparable specialist competitor.
• NDA Group: Regulatory affairs and drug development consultancy with established pharma and combination product expertise across EU and US markets — a peer competitor in the regulatory strategy niche.

Others

• Regulatory Affairs Professionals Society (RAPS): Professional membership organisation offering regulatory training and certification in medical devices and pharma — an ecosystem/training peer overlapping with CPMD's training and coaching line.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/combination-products-and-medical-devices-ltd

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about COMBINATION PRODUCTS AND MEDICAL DEVICES CONSULTING LTD