M4Q Revision 2: Shaping the Future of Quality Submissions
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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Author Right the First Time.
When creating dossiers for new products, different strengths, or various countries, it is common to rework and duplicate documents. Consequently, the content remains identical, but submission-specific values like naming, cross-references, and document headers vary each time.
100% of our first-time submissions have been accepted by health authorities since 2022.
With equally strong Pharmaceutical and Medical Device divisions, Celegence is uniquely positioned to provide combination product regulatory services.
The complexity of these products and the increasing regulatory scrutiny leads biopharmaceutical and medical device companies to seek industry experts to navigate through the challenging regulatory landscape to ensure the successful development and timely commercialization of their combination products.
Our clients in the combination products category benefit from our fully integrated team structure and ability to support their regulatory consulting and medical writing needs as a single provider.
Pharmaceutical Services
Medical Device Services
Creation and development of a regulatory strategy for combination products, in consideration with the specific requirements of the relevant regulatory authorities.
The preparation of regulatory submissions for combination products, including clinical trial applications, marketing authorization applications, and post-market surveillance reports.
Author/co-author of relevant documents for combination product dossier.
Ensuring compliance with the relevant regulatory requirements for combination products.
Keeping companies informed of up-to-date information on the latest regulatory developments around combination products.
Providing companies with training and education on the regulatory requirements for combination products.
Classify combination products under the relevant regulatory frameworks.
Conduct an assessment of the risks associated with combination products and develop mitigation strategies.
Develop and implement quality and compliance assurance systems for their combination products.
Support companies to develop a Post Marketing Surveillance for their combination products.
SME | Director, Medical Device
Joseph has 20 years experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).
Key experience includes preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE and notified body opinion submissions. Joseph has worked on diabetes management devices, nicotine replacement therapy (NRT) devices and pressurised metered dose inhalers (pMDI); Joseph has worked for small, medium and large Biotech companies such as Roche, OBG Pharmaceuticals and Kind Consumer Ltd.
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Principal SME, Pharmaceutical Services
Based in the Netherlands, Maurice has over 27 years’ experience in the pharmaceutical and biotech industry, mainly supporting pre-approval drugs and biologics for oncology, pulmonary and cardiovascular indications, with extensive experience in developing regulatory strategies, leading cross-functional teams in health authority interactions (Scientific Advice, both on national and EU level) regulatory intelligence and applications including document development to support applications such as MAAs, CTAs, EU & US Orphan Drug Applications, PIPs, iPSPs, IND Annual Reports and DSURs. He holds a Master’s degree in Medical Biology from the University of Utrecht and a Doctorate in Medicines from the University of Leiden, Netherlands.
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Head of Regulatory Affairs
Marloes provides regulatory affairs consultancy and services to both big- and small-sized pharmaceutical companies, covering a wide variety of products.
Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Awarded DIA Leader of Tomorrow in 2016. Helped author the biosimilar guidelines across the globe.
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Combination products are products that are composed of a combination of a drug a medical device and/or a biological product. A combination product will consist of at least two of these constituent parts.
Combo products are regulated by both the pharmaceutical and medical device agencies. The regulatory pathway for combination products is complex and varies by region.
As the demand for combination products continues to grow, the regulatory landscape is likely to evolve. The biopharmaceutical and medical device agencies are working together to develop harmonized guidelines for combination products. These guidelines are designed to streamline the regulatory process and make it easier for companies to develop and bring combination products to market.
Combination products are therapeutic and diagnostic products that combine two or more regulated components (drug, device, or biologic). They are categorized based on the primary mode of action (PMOA):
Drug-Led Combination Products: The primary effect comes from the drug (e.g., prefilled syringes, metered-dose inhalers, drug-eluting stents).
Device-Led Combination Products: The primary effect is from the device, but it contains or delivers a drug (e.g., drug-coated balloons, antimicrobial wound dressings).
Regulated by the Office of Combination Products (OCP), which assigns them to the appropriate lead center (CDER, CDRH, or CBER) based on PMOA.
Drug-Led: Governed under a New Drug Application (NDA) / Biologics License Application (BLA) with device aspects reviewed under 21 CFR 820 (Quality System Regulation).
Device-Led: Reviewed under a Premarket Approval (PMA), 510(k), or De Novo pathway, requiring demonstration of drug-related safety and effectiveness.
Key Challenge: Aligning cGMP (drugs) and QSR (devices) requirements.
Drug-Led: Assessed under Medicinal Product Regulation (EU 2019/6 or Directive 2001/83/EC) with device conformity assessed via Annex I of MDR 2017/745.
Device-Led: Governed by the Medical Device Regulation (MDR 2017/745), with medicinal components requiring an EMA scientific opinion.
Key Difference: MDR imposes stricter clinical evaluation requirements for device-led products than FDA.
Japan: Drug-led under PMDA Pharmaceutical Affairs Law, device-led follows Shonin or Ninsho pathway.
China:: NMPA governs approval, requiring separate evaluations for drug and device components.
Key Trend: Growing need for harmonization and reliance pathways, but substantial regional variation remains.
A global regulatory consultancy brings
Regulatory Strategy & Classification – Determining correct PMOA and most efficient approval pathway.
GMP & QMS Integration – Aligning pharmaceutical GMPs and device QSR/MDR compliance.
Global Market Access – Supporting multi-region submissions (FDA, EMA, PMDA, NMPA).
Clinical & Post-Market Compliance – Ensuring regulatory adherence from development through post-market surveillance.
16 Dec, 2025
13 Nov, 2025
11 Nov, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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