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.

They are regulated by both the pharmaceutical and medical device agencies. The regulatory pathway for combination products is complex and varies by region. In the United States, depending upon the primary mode of action (PMOA) combination products are regulated by the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). In the European Union, combination products are regulated by the European Medicines Agency (EMA) and the Medical Devices Directive (MDR).

The importance of the right services for clients in the CMC regulatory affairs combination products landscape is further highlighted by the growing complexity of these products and the increasing regulatory scrutiny they face. As combination products become more sophisticated, so do the challenges associated with their development and regulatory approval. The bio-pharmaceutical and medical devices companies seek industry experts to navigate through the complex regulatory landscape to ensure the successful development and timely commercialization of their combination products.

As the demand for combination products continues to grow, the regulatory landscape is likely to evolve. The bio/pharmaceutical 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.

Our Combination Products Consultancy Services Include:

  • Regulatory strategy development: Creation and development of a regulatory strategy for combination products, in consideration with the specific requirements of the relevant regulatory authorities.

  • Regulatory submissions preparation: The preparation of regulatory submissions for combination products, including clinical trial applications, marketing authorization applications, and post-market surveillance reports.

  • Medical writing: The author/co-author of relevant documents for combination product dossier.

  • Regulatory compliance: Ensuring compliance with the relevant regulatory requirements for combination products.

  • Regulatory intelligence: Keeping companies informed of up-to-date information on the latest regulatory developments in the area of combination products.

  • Training and education: Providing companies with training and education on the regulatory requirements for combination products.

Additional Information

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Pharmaceutical Industry Regulatory Affairs - Celegence

Expertise and Guidance

Combination products present unique regulatory challenges due to their multifaceted nature as a combination of pharmaceuticals, biologics and/or medical devices. Navigating this complex regulatory landscape requires specialist knowledge and expertise. Celegence RA consultants bring this expertise to the table, providing guidance on classification, clinical trial design, documentation, interaction with regulators, and submission strategies.

Efficient and Cost-Effective Development:

Engaging experienced Celegence consultants can streamline the development process and reduce costs associated with delays or regulatory setbacks. Celegence consultants can assist companies to identify potential regulatory difficulties early on, preventing costly missteps and ensuring timely product approval.

Risk Management and Mitigation:

Combination products often involve complex interactions between the drug and device components, raising potential safety and efficacy concerns. Regulatory affairs consultants from Celegence can support companies to identify, assess, and mitigate these risks through comprehensive risk management strategies.

Regulatory Compliance:

Ensuring compliance with ever-evolving regulatory requirements is crucial for the successful development and commercialization of combination products. Celegence consultants stay up-to-date on regulatory changes and guide companies on the adherence to these requirements, reducing the risk of regulatory non-compliance.

Accelerated Market Entry:

By providing subject matter expert guidance and support, Celegence consultants can ensure companies expedite the regulatory approval process, bringing their combination products to market faster and gaining a competitive edge. 

 In addition to these general services, we can provide specialized services in areas such as: 

  • Combination product classification: Classify combination products under the relevant regulatory frameworks.

  • Risk assessment: Conduct an assessment of the risks associated with combination products and develop mitigation strategies.

  • Quality and compliance assurance: Develop and implement quality and compliance assurance systems for their combination products.

  • Post-market surveillance: Support companies to develop a Post Marketing Surveillance for their combination products.

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How to Get Started with Celegence Combination Products Consultancy Services

To get started with Celegence Combination Products Consultancy services, please contact us today. We would be happy to discuss your specific needs and provide you with a quote.

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