Common Technical Document Module 1 Support

CTD Module 1 includes administrative information, regional documents, and an overview of the lifecycle. It also encompasses commitments and declarations, facilitating an understanding of the regulatory status and intentions. Other components of Module 1 that cannot be missed in an initial application are the Risk Management Plan (RMP) and the Patient Leaflet User Test. The RMP belongs to the Information relating to Pharmacovigilance and the User Test entails that a Patient Leaflet needs to undergo a user consultation to ensure that it is legible, clear and easy to use for the targeted patient group.

We have extensive experience with regulatory requirements across various regions, including the FDA, EMA, and others. Our consultants tailor submissions to meet specific regional guidelines, ensuring compliance and enhancing submission acceptance rates.

Mock-ups are essential components of CTD Module 1 because they visually represent your product's labeling and packaging. They ensure that key information is communicated clearly and accurately to regulatory authorities and consumers. The importance of artwork lies in their role in demonstrating compliance with labeling regulations, which vary significantly across different countries.

Each region has its own set of labeling requirements, including mandatory elements such as ingredient lists, usage instructions, and safety warnings. Compliance with these regulations is crucial to avoid delays or rejections of your submission, but above all to ensure safe use by the consumer. Additionally, different countries may have specific design guidelines that dictate how information should be presented, such as font size, layout, and the use of symbols or warning labels.

Some countries also require separate approvals of the mock-ups before your product can be marketed. Ensuring that these materials adhere to local requirements is vital for expediting the approval process and minimizing the risk of non-compliance issues.