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EU/UK Medicinal Product (MAA)

Helping bring medicinal drug products and devices to market to improve patient well-being

Building the scientific evidence and insight regulatory authorities need to evaluate the quality, safety, and efficacy of your medicinal drug product or device. We can also support with the ongoing maintenance and monitoring of a product’s benefit/risk ratio.

man writing at desk

What is an MAA? 

A Marketing Authorization Application (MAA) is the regulatory pathway for authorizing new medicines and drug/device combination products. It is required when a manufacturer wants to bring a medicinal product to market and includes both new and generic drug products. If you plan to register your drug or drug/device combination in the UK or EU, we can help bring your product to market.

An MAA provides comprehensive information enabling regulatory agencies to assess the product’s quality, safety, and efficacy in the form of a Common Technical Document (CTD). It also evaluates the ability of the future marketing authorization holder (MAH) to ensure ongoing drug product or device stewardship to maintain a suitable benefit/risk ratio for users. 

Our Full-Service MAA Testing and Consultancy Package

Submitting an MAA requires extensive expertise across multidisciplinary scientific areas such as toxicology, physiology, chemistry, biochemistry, and environmental assessment. Our scientific and regulatory consultants have years of MAA experience across different industry sectors and have worked on several successful marketing authorizations. We offer a fully integrated service that includes analytical testing, integrated with scientific strategy, technical writing, troubleshooting, and analysis supported by experience working with global regulatory bodies.

Scientific Strategy Definition

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.

Regulatory Authority Engagement

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.

Dossier Compiling, Writing, and Submission

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.



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.



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


CA/CE Marking Support for Medical Devices

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

Project Management

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.

MAA Submission Modules

Except for Module 1 of the MAA, which is region specific, a CTD (Modules 2 to 5) is common to almost all global applications in addition to the UK and EU applications. There are differences in some regions, so please contact us for more information if you are launching in markets outside of the UK or EU.

Module 1: Administrative and Prescribing Information

Module 2: High-Level Summaries

Module 3: Quality Documentation

Module 4: Non-Clinical Documentation

Module 5: Clinical Documentation

Module 1: Administrative and Prescribing Information

  • Application form
  • Brief overview of product characteristics
  • Labelling text and mock-ups
  • Experts’ information
  • Risk assessments related to the environment
  • Orphan market exclusivity information
  • Description of the pharmacovigilance system
  • Risk management plan


The CTD Triangle

Broughton CTD Triangle

MAA Focus Industry Areas

Our team of scientists and regulatory experts have a broad range of MAA experience working across a variety of industry areas:

  • Generic and hybrid drug applications
  • Medicinal cannabis products
  • Inhaled medical devices and drug/device combinations
  • Next generation nicotine delivery products and NRTs
  • Novel smart devices
Pharmaceutical tablets in blister packs, different colours, shapes and sizes
Doctor and patient with inhaler

Expert Support Throughout the Application

There are three distinct moments when expert regulatory consultancy will positively impact an MAA application. Our team brings in-depth experience working with regulatory bodies and can ensure these essential meetings are executed to ensure your success.

1.    Pre-submission meetings

Pre-submission meetings provide an early opportunity to engage with regulatory agencies and are critical to facilitate the validation and smooth evaluation passage of marketing applications. We have successfully led pre-submission meetings with the MHRA, EMA, and local competent authorities. 

2.    Critical Findings and Engagement

At the end of the review procedure, you will receive observations and critical findings if major approval issues remain. The authorization won't be granted until the critical items are resolved satisfactorily. Preparation for these interactions is vital to maximizing the chances of approval. Our regulatory experts are highly experienced at preparing and supporting clients through the process, providing advice on strategy for the interactions.

3.    Re-examinations

Unfortunately, sometimes resolving all issues with an application is impossible, and a Negative Opinion is received. It is, however, possible to request a re-examination of the application. Ensuring optimized strategy and execution for this re-examination is key to the outcome. Our regulatory experts will assist with re-examination procedures even where we have not previously been involved in the submission to help you reach a successful conclusion.

Speak to a Regulatory Expert 

Speak to a scientific regulatory consultant about your medicinal drug product or device to learn how we can help ensure regulatory authorization and compliance.

Contact Us

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Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts.

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