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COMBINATION PRODUCTS COMPLIANCE COMBINATION PRODUCT COMPLIANCE Instructor Michael Gross, Ph.D., RAC Principal Consultant Chimera Consulting North America LLC November 1819, 2015 Chemical Heritage
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How to fill out combination product compliance
How to fill out combination product compliance:
01
Understand the regulatory requirements: Start by familiarizing yourself with the regulatory guidelines and requirements specific to combination products. These may vary depending on the type of product and the market you are targeting.
02
Identify the primary mode of action: Determine whether your combination product is primarily a drug, device, or biological product. This will determine which regulatory pathway you need to follow and the applicable regulations to comply with.
03
Determine the classification: Determine the classification of your combination product based on its intended use and mode of action. This will help you determine the level of regulatory scrutiny and the specific requirements for safety, efficacy, and quality.
04
Establish a compliance strategy: Develop a comprehensive compliance strategy that outlines the necessary steps and actions required to meet the regulatory requirements. This may involve conducting studies, gathering data, and ensuring adherence to good manufacturing practices.
05
Prepare the required documentation: Gather and prepare all the necessary documentation, including product labeling, manufacturing procedures, quality control measures, and clinical data (if applicable). This documentation will be reviewed by regulatory authorities to evaluate the safety and effectiveness of the combination product.
06
Submit the application: Depending on the regulatory pathway chosen, submit the required application and supporting documents to the appropriate regulatory authority. Ensure that all information is accurate, complete, and follows the specified format.
Who needs combination product compliance?
01
Pharmaceutical companies: Pharmaceutical companies that develop combination products as part of their product portfolio need to ensure compliance with combination product regulations. This includes companies that produce drug-device combinations, biologic-device combinations, or drug-biologic combinations.
02
Medical device manufacturers: Manufacturers of medical devices that are used in combination with drugs or biologics need to comply with combination product regulations. These manufacturers may need to conduct additional studies, provide additional labeling, or adhere to specific quality control measures.
03
Biotechnology companies: Biotechnology companies that develop combination products, such as gene therapies or cell-based therapies combined with a medical device component, need to comply with combination product regulations. These companies need to ensure the safety, efficacy, and quality of their products.
In summary, filling out combination product compliance involves understanding the regulatory requirements, determining classification, developing a compliance strategy, preparing required documentation, and submitting the application. Various stakeholders, including pharmaceutical companies, medical device manufacturers, and biotechnology companies, need to comply with combination product regulations.
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What is combination product compliance?
Combination product compliance refers to adhering to regulations and guidelines set forth by regulatory authorities when developing, manufacturing, and marketing combination products.
Who is required to file combination product compliance?
Manufacturers of combination products are required to file combination product compliance.
How to fill out combination product compliance?
Combination product compliance can be filled out by providing the necessary information and documentation required by regulatory authorities.
What is the purpose of combination product compliance?
The purpose of combination product compliance is to ensure the safety, efficacy, and quality of combination products for the end user.
What information must be reported on combination product compliance?
Information such as product composition, manufacturing process, labeling, and packaging must be reported on combination product compliance.
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