Drug-Device Combination Product Consulting for Global Regulatory Compliance
NKB Regovanta provides specialized consulting for drug-device combination products, supporting pharmaceutical and medical device manufacturers in defining global regulatory pathways, preparing compliant design and development documentation, managing lifecycle product risks, and compiling submission-ready technical files. Our integrated approach aligns both drug and medical device regulatory requirements, reducing uncertainty and accelerating market access across the US FDA, EU MDR Article 117, UK MHRA, CDSCO India, and global markets.
FDA 21 CFR 4
Combination Product cGMP
EU MDR Art 117
Notified Body Opinion (NBOp)
ISO 14971
Integrated Risk Management
IEC 62366-1
Human Factors & Usability
Drug-Device Combination Products Documentation Service Portfolio
Click on each service module below to explore our detailed documentation, verification protocols, and regulatory deliverables.
Design Planning & User Needs
Design planning, clinical stakeholder user needs, design inputs & outputs documentation tailored for drug-delivery device interfaces.
Design Transfer & DHF / DMR
Design transfer, change control, Structured Design History File (DHF) & Device Master Record (DMR) documentation support.
Design Verification & Validation
Design verification, analytical & clinical validation & design review documentation support across delivery tolerances and container closure integrity.
Technical File & Specifications
Technical File, Design Dossier & Product Specifications File preparation for global compliance across pharmaceutical and medical device standards.
What Sets Us Apart in Combination Product Consulting
Global exposure, structured thinking, and execution-ready regulatory and technical expertise.
Extensive Experience Across Drug, Device & Combination Regulations
Deep expertise spanning FDA 21 CFR Part 4, 21 CFR Part 820 / QMSR, ISO 13485, EU MDR 2017/745 Article 117, and international ICH guidelines.
Integrated Drug & Device Quality Management Systems
Bridging the gap between cGMP pharmaceutical manufacturing (21 CFR Part 210/211) and medical device design controls (21 CFR Part 820 / ISO 13485).
Global Consulting Support from Concept to Submission
End-to-end strategic advisory covering PMOA determination, DHF structuring, human factors engineering, testing coordination, and dossier assembly.
Proven Capability in Risk Management, DHF & Audit Readiness
Robust ISO 14971 risk management, CAPA implementation, Notified Body Opinion (NBOp) defense, and global health authority query resolution.
Integrated Strategy Across Drug and Device Regulatory Domains
Navigating the convergence of pharmaceutical and medical device regulations requires specialized, cross-functional mastery. At NKB Regovanta, we assist combination product developers in formulating defensible regulatory strategies, establishing ISO 13485 / 21 CFR Part 820 design controls, executing ISO 14971 hazard analyses, generating IEC 62366-1 usability data, and compiling compliant dossiers for FDA IND/NDA/BLA submissions and EU MDR Article 117 Notified Body Opinions. This structured rigor minimizes deficiency cycles, safeguards compliance, and expedites worldwide commercialization.
Strategic Value Across Every Stage of Product Development
End-to-End Regulatory Consulting
Holistic regulatory lifecycle management from early qualification and classification through design controls, testing, and dossier authorization.
Dual Compliance Integration
Synchronizing pharmaceutical safety, stability, and efficacy with medical device hardware reliability, software validation, and usability.
Design Control & DHF Mastery
Comprehensive Design History File (DHF), Device Master Record (DMR), and design transfer documentation built for rigorous audit inspection.
Audit-Ready Dossiers & Submissions
Submission-ready technical documentation formatted for US FDA eSTAR / IND / NDA / BLA, EU Article 117 NBOp, UK MHRA, and CDSCO licensing.
Explore Related Regulatory Services
Cross-market regulatory and technical documentation capabilities
Frequently Asked Questions: Drug-Device Combination Products
What is a drug-device combination product?
A drug-device combination product is a therapeutic health product composed of two or more regulated components—such as a drug and a medical device, a biologic and a device, or a drug and a biologic—that are physically combined as a single entity, co-packaged together, or cross-labeled for combined use. Common examples include prefilled syringes, auto-injectors, insulin delivery pens, drug-eluting cardiovascular stents, transdermal therapeutic patches, metered-dose inhalers (MDIs), and wound dressings infused with antimicrobial agents.
How are combination products regulated by the US FDA?
In the United States, the FDA regulates combination products under 21 CFR Part 3 and 21 CFR Part 4 based on the product's Primary Mode of Action (PMOA). The Office of Combination Products (OCP) assigns the lead review jurisdiction to the appropriate center—CDER (Center for Drug Evaluation and Research) for drug PMOA, CDRH (Center for Devices and Radiological Health) for device PMOA, or CBER (Center for Biologics Evaluation and Research) for biologic PMOA. Even when CDER leads the review of an NDA/BLA, the device constituent must demonstrate compliance with applicable 21 CFR Part 820 design controls.
What is Article 117 under EU MDR 2017/745?
Article 117 of the EU Medical Device Regulation (EU MDR 2017/745) amended Directive 2001/83/EC regarding medicinal products. For single integral drug-device combination products governed as medicinal products (such as prefilled syringes, prefilled pens, or dry-powder inhalers intended for administration of a specific medicine), the marketing authorization application (MAA) to the EMA or national competent authority must include a Notified Body Opinion (NBOp) confirming that the device component complies with the relevant General Safety and Performance Requirements (GSPRs) of Annex I of the EU MDR.
How is the Primary Mode of Action (PMOA) determined?
The Primary Mode of Action (PMOA) is the single mode of action expected to make the greatest contribution to the overall intended therapeutic effect of the combination product. If the therapeutic effect is primarily achieved by pharmacological, immunological, or metabolic means, the product is regulated as a drug/biologic. If the primary effect is achieved by mechanical, physical, or structural means, the product is regulated as a medical device. Manufacturers can file a Request for Designation (RFD) or Pre-RFD with the FDA to obtain a binding jurisdictional assignment.
What documentation is required for a drug-device combination product?
Documentation requirements span both pharmaceutical and medical device domains: product classification and PMOA justification; Design History File (DHF) including user needs, design inputs, design verification and validation (V&V), design reviews, and design transfer; ISO 14971 Risk Management File (URRA, dFMEA, pFMEA); usability engineering files (IEC 62366-1); container-closure integrity and compatibility studies (extractables/leachables); ISO 10993 biocompatibility; sterilization validation; packaging and shelf-life stability; clinical evaluation and delivery accuracy evidence; and regulatory submission dossiers.
Which quality and risk standards apply (ISO 13485, ISO 14971, IEC 62366)?
Manufacturers must implement dual quality and risk frameworks: ISO 13485 / FDA 21 CFR Part 820 (QMSR) for medical device design controls, ISO 14971 for comprehensive risk management, IEC 62366-1 for usability and human factors engineering, ISO 10993 for biological evaluation, and relevant cGMP standards (FDA 21 CFR Part 210/211, EU GMP, WHO GMP) for pharmaceutical manufacturing.
What is the role of a Notified Body Opinion (NBOp)?
A Notified Body Opinion (NBOp) is a formal assessment issued by a designated EU MDR Notified Body confirming that the device constituent of an integral medicinal product satisfies all applicable Annex I GSPRs. The pharmaceutical marketing authorization holder must submit this NBOp document as part of the Marketing Authorization Dossier (Module 3) to the European Medicines Agency (EMA) or national competent authorities before marketing authorization can be granted.
How long does combination product approval take?
Combination product approval timelines depend on the regulatory jurisdiction, product complexity, PMOA classification, and submission pathway. In the US, an NDA/BLA review typically takes 10 to 12 months following IND phases, while a 510(k) pathway for a device-led combination product takes approximately 3 to 6 months. In the EU, obtaining a Notified Body Opinion (NBOp) generally takes 3 to 6 months, followed by the standard 210-day MAA review by the EMA or national authorities.
Which global regulatory authorities govern drug-device combination products?
Key regulatory authorities include the US Food and Drug Administration (FDA - CDER/CDRH/CBER/OCP), the European Medicines Agency (EMA) and EU Notified Bodies, the UK Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, Australia's Therapeutic Goods Administration (TGA), Japan's PMDA, Saudi Arabia's SFDA, and India's Central Drugs Standard Control Organization (CDSCO).
How does NKB Regovanta support drug-device combination product documentation?
NKB Regovanta provides end-to-end regulatory consulting for combination products: regulatory pathway strategy, PMOA determination, Design History File (DHF) authoring, ISO 14971 risk management, human factors usability studies (IEC 62366), EU MDR Annex I GSPR checklists, Notified Body Opinion (NBOp) dossier compilation, technical file gap assessments, and post-market surveillance systems. Our consultants ensure audit readiness and accelerate global market approvals.
Planning a Drug-Device Combination Product Regulatory Submission?
Connect with our senior combination product regulatory strategists to structure your PMOA classification, DHF design controls, risk files, and EU MDR Article 117 Notified Body Opinion.