OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION
Drug-Device Combination Products – Regulatory & Development Consulting
Operon Strategist provides specialized consulting for drug-device combination products, supporting manufacturers in defining regulatory pathways, preparing compliant design and development documentation, managing 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 global markets.
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Operon ElevatePlus
Drug-Device Combination Products Documentation Service Portfolio
Regulatory Strategy & Product Classification
Determine drug-device combination product classification and regulatory applicability
Identify applicable regulatory pathways under FDA 21 CFR Part 4, 21 CFR Part 820/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971 & ICH guidelines
Assess Primary Mode of Action (PMOA) and lead regulatory authority
Develop market-specific regulatory and approval strategy roadmap
Design & Development Documentation
Design planning, user needs, design inputs & outputs documentation
Design transfer, change control, Structured Design History File (DHF) & Device Master Record (DMR) documentation
Design verification, validation & design review documentation support
Technical File, Design Dossier & Product Specifications File preparation for global compliance
Risk Management & Quality Systems
Risk analysis and mitigation aligned with ISO 14971
Integration of quality system requirements across device QMS and drug cGMP expectations
Development of compliant procedures for design controls and lifecycle management
CAPA & Compliance Readiness
Development and implementation of CAPA systems specific to combination products
Root cause analysis and corrective action planning
Change control and documentation traceability for audit readiness
Regulatory Submission Support
Preparation of documentation for regulatory submissions in major global markets
Support for interactions with regulatory authorities
Response to deficiency letters, queries, and review comments
Global Market Entry Planning
Harmonized regulatory strategies for multi-country market access
Alignment of development timelines with regulatory expectations
Ongoing compliance support post-approval
What Sets Us Apart
Extensive Experience Across Drug, Device & Combination Product Regulations
Expertise in FDA 21 CFR Part 4, 21 CFR Part 820, ISO 13485, & EU MDR Requirements
Global Consulting Support from Concept Development to Regulatory Submission
Proven Capability in Risk Management, CAPA, DHF & Audit Readiness
Operon Drug-Device Combination Products Documentation Advantage
End-to-End Regulatory Consulting for Drug-Device Combination Products
Integrated Approach Covering Both Drug & Device Compliance Requirements
Strong Alignment with Quality Management & Design Control Systems
