Combination Products

Navigating regulatory pathways can often feel like a maze, leading to uncertainty and potential pitfalls in the submission process. This is even more so when it comes to combination products.

Nothing is more disheartening than investing significant time and resources into developing your combination product, only to face rejection from regulatory authorities due to unclear expectations or insufficient data.

At Qbd Group, we offer comprehensive solutions to navigate the complex process of registering these innovative products in both the European Union (EU) and the United States (US).

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Device-led Combination Products

If your product is classified as a medical device with an ancillary medicinal substance, it must comply with EU MDR 2017/745.

The Notified Body must consult the EMA for a scientific opinion on the excipient if:
- It is derived from human blood or plasma.
- It has been previously assessed by the EMA.
- It falls under the centralized procedure.

In other cases, the Notified Body may consult either:

The National Competent Authority, or
The EMA (e.g. if the same substance has been evaluated before).

Consult our flowchart

Medicinal Product-led Combination Products

If your product is primarily a medicinal product, the combination is regulated under the Medicinal Product Directive (2001/83/EC).

The type of product — and how the medical device is integrated — influences the required documentation and regulatory steps.

Types of medicinal combination products:

Integrated: The device is part of the product (e.g. prefilled syringe).
Co-packaged: Medicinal product and device are packaged together (e.g. inhaler + cartridge).
Referenced: The product refers to a separate device used during administration.

Consult our flowchart

Your regulatory roadmap: key steps

Use the flowchart below as a guide to determine:

Which authority is involved.
What quality documentation is needed.
How to prepare your submission for compliance.

Examples of Combination Products

Example	Primary Mode	Pathway
Drug-eluting stent	Device	MDR + EMA opinion
Prefilled syringe	Drug	MPD
Contraceptive patch	Drug	MPD
Coated catheter	Device	MDR

Learn more about the regulatory pathway in the USA

Medical device combination products - what regulations should you apply before marketing them in the EU - Medical device combination products what regulations should you apply before marketing the

Regulatory pathway in the USA

Combination products in the US are regulated by the FDA based on their Primary Mode of Action (PMOA). This determines which FDA center oversees the review and which application types are required.

Why partner with us?

New Manufacturer Incident Report template and IMDR terminologies for categorized Adverse Event Reporting released

Step 1: identify the lead FDA center

Depends on the PMOA (drug, device, or biologic).
If unclear, you may submit a Request for Designation (RFD) to the FDA.

Step 2: determine the type of investigational application

Depending on the PMOA, one of the following may apply:

IND (Investigational New Drug Application) → Used when the primary mode is drug or biologic.
IDE (Investigational Device Exemption) → Used when the primary mode is device.

Take into account the combination product as a whole, not just its individual components.

Stay-Ahead-of-Compliance-How-to-Effectively-Manage-Your-Yearly-Audits-QbD-Group-2

Step 3: select the appropriate marketing application

The marketing application depends on the constituent part with the PMOA:

PMOA	Marketing Application
Drug	NDA (New Drug Application) or ANDA (Abbreviated NDA)
Biologic	BLA (Biologics License Application)
Device	PMA (Premarket Approval), De Novo, or 510(k) Notification

Why choose us for combination product lifecycle management?

QbD Group is your trusted partner in navigating the complex regulatory landscape of combination products. Our expertise ensures a streamlined pathway to market while maintaining compliance with all regulatory requirements. Here's how we stand out:

Tailored regulatory strategy

We help you develop a custom regulatory roadmap to ensure your product meets all compliance and market entry requirements.

Expert guidance on procedures

Our team guides you in selecting the most suitable regulatory procedure for your product, saving time and minimizing hurdles.

End-to-end lifecycle management

From concept to market launch, we offer holistic support for every stage of your combination product’s journey.

In-depth regulatory knowledge

Leverage our extensive expertise to navigate stringent requirements confidently and accelerate your product’s market readiness.

Our offerings for Pharma in

All

QPPV / Local Representative

Ensure global compliance with QbD's QPPV and Local Representative services. Gain expert support for safety oversight and regulatory obligations worldwide.

Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

Stay compliant with QbD Group's Literature Monitoring Services. Detect safety signals, ensure timely reporting, and enhance your vigilance strategy.

ICSR Management

Maintain compliance and protect patient safety with QbD's expert management of individual case safety reports (ICSRs). Simplify safety reporting processes for clinical...

Pharmacovigilance & Certified Blended Training

Empower your team with our certified pharmacovigilance training. Tailored courses to ensure compliance, mitigate risks, and enhance operational excellence.

Operational Software Compliance

Need seamless operational software compliance? QbD ensures your systems meet industry regulations, enhancing data security and reliability.

Digitalization

Our expertise in software implementation and IT partnerships ensures a seamless transition from traditional methods to advanced digital solutions, allowing you to...

AI/ML Compliance

Looking for guidance while developing software including AI-models? QbD offers AI/ML compliance support helping you be compliant with the latest standards and...

Data Governance

QbD Group offers data governance support, helping you comply with the latest regulations and shorten your path to market.

Software Validation, Central IT Systems

Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services. We specialize in Computer System Validation (CSV) to...

Data Integrity

Ensure your data's accuracy and consistency with our tailored data integrity services. We provide expert guidance on complying with the latest regulatory standards,...

Software Implementations

Transform your life science organization with our expert software implementation services. Our team ensures seamless integration and compliance, delivering customized...

IT Infrastructure Qualification

Ensure your IT systems meet regulatory standards with our IT infrastructure qualification services. We specialize in validating on-premises and cloud-based systems to...

Paperless Validation

Transform your validation process with our Paperless Validation service, offering a digital, efficient, and error-free solution for regulated industries. Say goodbye to...

Commissioning

Commissioning is crucial for getting your systems and equipment to perform at their best and safest. QbD Group is the expert in making sure your systems, utilities,...

Facility Qualification

Confirm that your facilities and HVAC (heating, ventilation, and air conditioning), cleanrooms, and monitoring systems, meet predetermined specifications and regulatory...

Utility Qualification

Identify and mitigate risks associated with facility and utility failures such as water systems (WFI, ROW…), gas systems and distribution networks. Keep up to date with...

Equipment Qualification

Ensuring that machinery, instruments, or systems used in production, testing, or any other processes consistently perform as intended.

Process Validation

Our experts are pleased to set up, improve and support the validation of your processes.

Cleaning Validation

QbD Group can support you in the validation and qualification of your cleanrooms, making sure your equipment is truly squeaky clean.

Analytical Method Validation

QbD Qualification & Validation uses advanced tools and strict testing methods to ensure your analytical methods are accurate, precise, and reliable.

Sterilization Validation

Ensure that your sterilization processes meet the most stringent standards, ensuring the integrity of your products and safeguarding public health.

Tech Transfer

Tech Transfer is a vital process in translating innovation into real-world applications, driving economic growth, and fostering collaboration and innovation. Ensure a...

Process & Product Support

In today’s competitive marketplace, optimization of processes and products can make a real difference. Working with QbD Group, you can trust that your processes and...

QC Chemical Analysis

Our GP certified QC laboratory can support your analytical needs from pharmacopoeial analysis of raw materials, active pharmaceutical ingredients (APIs), and...

Method Development

Method development and validation are essential to the drug development process to ensure the methods are well-defined and fit-for-purpose, and the results are robust...

Method Validation

To ensure that the methods meet regulatory requirements, we follow relevant ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals...

Stability Studies

Investigating the stability and shelf-life of a finished product is an important area of expertise at QbD Group’s Lab Services. We can help you determine the best...

Cleaning Validation

Effective cleaning is essential to protect patient safety, and we can help you define a best practice approach in setting up plans and protocols for cleaning validation....

Microbiological Services

We can support you with routine testing and validation of the microbiological purity of raw materials and finished medicinal products. We have in-house, project-based...

Environmental Monitoring

We have invested in state-of-the-art equipment to perform active air sampling, as well as compressed gas sampling (air, nitrogen, argon, etc.) for microbiological...

QP Batch Release

Our Lab Services have authorization for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC.Our own qualified persons (QPs) can certify...

Elemental Impurities

ICH Q3 described expectations regarding the control of elemental impurities in medicinal products or their excipients. Recently, authorities have been increasingly...

R&D Projects

QbD Group’s Lab Services is uniquely positioned to provide knowledge and customized solutions for the pharma industry.

Tracking Adverse Drug Reactions

Monitor and address adverse drug reactions with precision. QbD Group’s safety database solutions support regulatory compliance while prioritizing operational...

Vigilance and Pharmacoviglance Hotline Services

Emergencies don’t sleep and neither does our support. The One Vigilance hotline is open 24/7 all year round.

EudraVigilance Medicinal Product Dictionary (XEVMPD)

Achieve XEVMPD compliance effortlessly with QbD's expertise. Simplify your regulatory submissions and maintain up-to-date safety profiles for consistent, safe medicinal...

Safety Reporting & Signal Detection

Optimize your aggregate safety reporting with customized solutions from QbD. Manage risks, meet regulatory standards, and uphold patient safety with tailored strategies...

Project Management

Coordinate pharmacovigilance projects seamlessly with QbD’s project management expertise. Drive safety goals, meet compliance requirements, and improve operational...

Regulatory Intelligence

Stay ahead of evolving regulations with QbD’s regulatory intelligence services. Anticipate changes, address potential risks, and streamline compliance with informed,...

Strategic Planning

Align safety and business goals with QbD’s strategic planning services. Build a clear roadmap for compliance while maximizing value and operational efficiency for your...

Safety Signal Program

Enhance patient safety with QbD Group’s Safety Signal Program. Detect risks early, ensure compliance, and build trust with proactive safety solutions.

Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Streamline your pharmacovigilance compliance with QbD’s tailored QMS & PSMF services. Ensure efficiency, audit readiness, and global regulatory alignment.

Pharmacovigilance (PV) Audits

Ensure compliance & inspection readiness with QbD’s certified PV audits, mock inspections, and ISO services. Strengthen your pharmacovigilance systems now.

QMS Implementation

Optimize your quality management system with QbD's tailored QMS Setup services. Build a smart, scalable system that aligns with regulatory standards and drives value.

QMS Remediation & Support

Achieve operational excellence with QbD's QMS Remediation & Support services. Address gaps, sustain certification, and maintain smooth operations seamlessly.

QA Outsourcing

Simplify compliance and reduce costs with QbD Group’s Outsourced QA solutions. Tailored support to manage your QMS or specific quality functions effectively.

Qualified Person (QP) & Responsible Person (RP)

Meet regulatory requirements with QbD Group’s QP/RP services. Rely on expert support for batch release, GMP/GDP compliance, and operational continuity.

Annual Product Review (APR) & Product Quality Review (PQR)

Streamline APR/PQR processes with QbD Group’s expert support. Ensure compliance, timely reviews, and actionable insights for product quality and safety.

QA Audits & Remediation

Audits are viewed as a necessity. We strive to see any audit as an opportunity to gain more insights into the company itself and the quality management system, which...

RA Strategy for Pharma

Bringing your pharmaceuticals to the market requires a tailor-made strategy. We can help you to form that strategy and make it a success.

Drug Development

New pharmaceuticals must be manufactured to high-quality standards before they can be placed on the market. We support you from drug discovery to pre-clinical and...

Early Development

We can maximize your success by leveraging our expertise in regulatory consultations and strategic planning for First-in-Human trials.

Scientific Advice

Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Our regulatory experts can help you to interact with the required...

Regulatory Procedures

There are various procedures to register pharmaceutical drugs, depending on the type of drug and your intended route to market. Our experts will lead you to the right...

Submissions

Irrespective of the type of your regulatory procedure your applications for marketing authorization must be accompanied correctly by the required documentation. Our...

eCTD Publishing

The skills needed to confidently compile electronic submissions can take years of training, industry immersion and regulatory study. Let us be your guide for electronic...

Artwork & Labeling

Artwork and labeling play an important role in the marketing process of any pharmaceutical and are highly regulated. Our regulatory experts will help you to create...

Lifecycle Management

Our experts will accompany you throughout the whole Product Life Cycle Management (PLM) process – from its conception, through design and manufacture, to service and...

Information Officer

A qualified Information Officer from QbD Group can coordinate and monitor pharmaceutical organizations’ information management and marketing activities.

Orphan Diseases

Rare diseases deserve just as much attention as more common diseases. We can support you in the development of medicines for patients suffering from rare diseases.

Regulatory Intelligence

Regulations and standards may change every now and then, and manufacturers must be aware of those changes. Our consultants keep you on track at all times.

PDE-OEL Reports

We have a professional team of expert toxicologists to calculate the PDE value of any API and we offer the largest online library of high quality PDE reports available...

Nitrosamine Risk Assessment

Elaboration of comprehensive Nitrosamine Risk Assessment reports to ensure pharmaceutical product compliance with regulatory requirements regarding nitrosamine...

Organic Impurities Reports

We carry out toxicological evaluations of organic impurities according to ICH Q3A/B, assessing the toxicological risk and establishing a safety limit.

Extractables & Leachables Reports

Our extractables and leachables reports meet the highest quality standards. With rigorous scientific methodology and deep industry expertise, we help you ensure the...

Environmental Risk Assessment (ERA)

Assess the environmental profile of your pharmaceutical products with our detailed report. Identify, and mitigate the environmental risks associated with the life cycle...

Monitoring Studies

Keep up to date with standards and ensure the safety of your product. With more than 10 years providing Toxicology Services, membership to AETOX and certified by...

Clinical Regulatory Services

We help sponsors and manufacturers who want to perform a study in Europe (and beyond) to navigate through the MDR requirements to make sure their study gets approved by...

Clinical Pharmacovigilance Service

Ensuring comprehensive safety oversight is essential in clinical trials. Our expertise in pharmacovigilance could offer invaluable support.

Toxicology

QbD Group offers a set of Toxicology services, for your processes, applications, and equipment. We are EUROTOX certified and are members of AETOX.

Elemental Impurities Reports

Ensure compliance with elemental impurities regulations through QbD Group's expert risk assessments and tailored reports for pharmaceutical products, safeguarding safety...

Residual Solvents Reports

Ensure compliance and patient safety with QbD Group's residual solvent risk assessments, tailored to meet regulatory standards and quality requirements.

Linguistic Review

QbD Group offers expert linguistic review services to meet tight deadlines and regulatory requirements.

Landing in Europe

Accelerate your entry into the European life sciences market with QbD Group's expert regulatory support, compliance solutions, and strategic guidance for seamless...

Comprehensive Medical Information Services

Enhance patient safety and product trust with QbD Group's expert medical information services, ensuring timely, accurate responses and compliance throughout your product...

Why QbD Group?

At QbD Group, we provide deep expertise to guide life science companies through complex regulatory landscapes and ensure compliance throughout the product lifecycle.

Our team understands the stringent requirements needed to safely and effectively develop, approve, and distribute combination products.

Beyond market entry, we continue supporting businesses by managing critical processes that ensure the ongoing safety, efficacy, and compliance of their products before and after they reach patients.

Get in touch

+10 years of experience

Full lifecycle support

Global presence

Best managed company

Get in touch

Have questions about the regulatory pathways for your combination product?

We understand the complexities of navigating EU and US regulations. Whether you’re seeking clarity on the Primary Mode of Action (PMOA), determining the right regulatory pathway, or managing lifecycle requirements, our experts are here to help.

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Combination Products

Regulatory framework in Europe

Device-led Combination Products

Medicinal Product-led Combination Products

Your regulatory roadmap: key steps

Examples of Combination Products

Regulatory pathway in the USA

Step 1: identify the lead FDA center

Step 2: determine the type of investigational application

Step 3: select the appropriate marketing application

Why choose us for combination product lifecycle management?

Tailored regulatory strategy

Expert guidance on procedures

End-to-end lifecycle management

In-depth regulatory knowledge

Our offerings for Pharma in

QPPV / Local Representative

Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

ICSR Management

Pharmacovigilance & Certified Blended Training

Operational Software Compliance

Digitalization

AI/ML Compliance

Data Governance

Software Validation, Central IT Systems

Data Integrity

Software Implementations

IT Infrastructure Qualification

Paperless Validation

Commissioning

Facility Qualification

Utility Qualification

Equipment Qualification

Process Validation

Cleaning Validation

Analytical Method Validation

Sterilization Validation

Tech Transfer

Process & Product Support

QC Chemical Analysis

Method Development

Method Validation

Stability Studies

Cleaning Validation

Microbiological Services

Environmental Monitoring

QP Batch Release

Elemental Impurities

R&D Projects

Tracking Adverse Drug Reactions

Vigilance and Pharmacoviglance Hotline Services

EudraVigilance Medicinal Product Dictionary (XEVMPD)

Safety Reporting & Signal Detection

Project Management

Regulatory Intelligence

Strategic Planning

Safety Signal Program

Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Pharmacovigilance (PV) Audits

QMS Implementation

QMS Remediation & Support

QA Outsourcing

Qualified Person (QP) & Responsible Person (RP)

Annual Product Review (APR) & Product Quality Review (PQR)

QA Audits & Remediation

RA Strategy for Pharma

Drug Development

Early Development

Scientific Advice

Regulatory Procedures

Submissions

eCTD Publishing

Artwork & Labeling

Lifecycle Management

Information Officer

Orphan Diseases

Regulatory Intelligence

PDE-OEL Reports

Nitrosamine Risk Assessment

Organic Impurities Reports