MAA Preparation & Submission

Meticulous, end-to-end management of your marketing authorisation application.

The Critical Path to Your Market Authorisation

The Marketing Authorisation Application (MAA) is the single most critical milestone in your product’s journey. It represents the culmination of all your development data, and its quality, accuracy, and strategic positioning are paramount.

At TEDDZ Regulatory, we are experts in the execution of flawless submissions. We manage the entire process, from technical compilation to agency liaison, ensuring your dossier is comprehensive, compliant, and submitted efficiently to avoid validation delays.

Our MAA Submission Services

We conduct a rigorous, high-level review of your complete data package (Modules 1-5) against current regulatory requirements. We identify any potential gaps, inconsistencies, or ‘red flags’ that could trigger questions during assessment, giving you time to address them before submission.

Your submission’s technical format is as important as its content. We are experts in eCTD (electronic Common Technical Document) publishing. We manage the entire lifecycle of your application, from compiling and validating the initial eCTD sequence to publishing all subsequent follow-up sequences, ensuring 100% compliance with agency gateways.

We act as your dedicated regulatory point of contact. We manage all formal correspondence with the regulatory authorities (EMA, MHRA, etc.), coordinate your responses to questions (RTQs), and provide seamless project management to keep your submission on track and all stakeholders informed.

During the assessment phase, responding to agency questions (like the 120-day List of Questions) is critical. We project-manage this process, helping your team interpret the questions, formulate scientifically sound responses, and ensure all associated documents are prepared and submitted on time.

Your Partner Across Key Markets

United Kingdom

Deep expertise in all MHRA regulatory processes, including post-Brexit guidance, ILAP, and national submission requirements.

European Union

Navigating the complexities of the EMA centralised procedure (CP), as well as national procedures (DCP, MRP) with competent authorities.

Africa

Specialist knowledge of key African agencies, including NAFDAC (Nigeria), SAHPRA (South Africa), and Kenya’s Pharmacy & Poisons Board.

Ready to Plan Your Submission?

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