EU/UK Medicinal Product (MAA)

A strategy definition session will map the best approach for obtaining marketing authorization for your medicinal product. This will consider your company’s strategic objectives, product roadmap, and the data required to illustrate a clear risk/benefit ratio for users. We build the overall scientific strategy for your MAA project from the strategy definition phase. At this stage, we also discuss bridging strategies from previous submissions or consider future submissions to ensure the project gives you the most efficient plan for delivering your longer-term business objectives.

The strategy definition phase is essential for setting the project up for success. Having the right scientific strategy will save time and costs, plus decrease the risk of delays in the application process.

It is essential when considering an MAA to engage directly with the regulatory authorities before submission. A Broughton senior regulatory consultant can act as your authorized representative and work on your behalf to prepare scientific briefing documents, manage communications or conduct meetings with the regulator, and help you understand the nuances of the interactions with the agency.

Our consultants have years of experience working with global regulatory bodies and will ensure your MAA project is professionally managed.

An MAA submission requires a substantive dossier to be compiled and submitted. Compiling a dossier requires expertise in the regulatory process and multidisciplinary scientific areas such as toxicology, physiology, chemistry, biochemistry, and environmental assessment.

Our regulatory consultants have extensive experience compiling the different modules, building a strong narrative, and supporting the submission process. They have worked on several successful MAA projects that received marketing authorizations.

Scientific data from a range of analytical tests and studies are required to substantiate an MAA. Our MAA support services include analytical testing in our UK-based, compliant laboratories integrated with expert scientific analysis and problem-solving.

• Product Characteristics and Characterization 
• Product Safety Testing (devices)
• Method development and validation 
• Shelf-life and Stability Analysis 
• Manufacturing process support
• Raw material testing and selection 

The level of safety data required for an MAA will depend on the type of drug product or drug/device combination. A generic drug application may require less stringent safety data compared to a new drug application. Our regulatory experts can advise on the level of safety and clinical data required for your MAA.

• Toxicological Risk Assessments 
• Environmental Impact Assessment 

The level of clinical data required for an MAA will depend on the drug product or device type. It will also depend on if it is a generic drug application or for a new drug product. Our regulatory experts can advise on the level of safety and clinical data required for your MAA.

• Clinical Studies

If your medicinal drug product involves a delivery device that requires CA/CE marking, we can help ensure it complies with EU and UK standards for quality and safety in the target market.

Our team will assess whether the proper directive, requirement and harmonized standards have been considered. Helping to evaluate products to see if they comply with the relevant conformity assessment procedures and meet document requirements such as the Declaration of Conformity (DoC).

We can support with CE and UKCA marketing requirements for the following device categories.

• E-cigarettes and vape devices
• Novel inhalation devices
• Low-voltage electrical equipment

A senior scientific consultant with many years of industry-related experience will be appointed as a Technical Project Lead, ensuring open communication with your in-house experts to create a common purpose and high-quality outcomes.

The Technical Project Lead will be supported by an experienced Project Manager who will coordinate across your MAA project using various project management tools and processes, including Gannt planning tools and logs for managing risks and issues. They also ensure timely communication, accurate meeting notes, and that the project remains on track and within budget.