Authoring Module 1 documents for all types of regulatory activities
Creating and compiling your Module 1 documents
The importance of Module 1
Module 1 of a dossier is a critical component when registering and maintaining your products in global markets and must comply with local regulations and legislation. Module 1 of the dossier houses the administrative data of the applicant, product information, and additional declarations and annexes.
How PLG compiles documents for Module 1
We can guide, prepare, and compile this information for all markets and dossier types.
The information is prepared in collaboration with our local experts, and the relevant information from Modules 2 through 5.
We can translate the documents into the target market’s local language using our internal translation team if required.
Documents contained in Module 1
- Cover letter
- Application forms
- Product information
- Information about the experts
- Specific requirements for different types of applications
- Environmental risk assessment(s)
- Information relating to orphan market exclusivity
- Information relating to pharmacovigilance
- Information relating to clinical trials
- Information relating to pediatrics
- Responses to questions
- Annexes
- Declarations
The advantages of using PLG to support the compilation of your Module 1
Module 1 compilation requires market-specific knowledge and can be time-consuming, involving inputs from various stakeholders. We can support your team to ensure the accurate and timely completion of Module 1 to meet your submission timelines.
We have gained experience from compiling thousands of Module 1 documents for numerous health authorities globally, meaning you can trust that your submission and – significantly – your products are in the safest hands.
KEY FIGURES :
1000+
Average annual volume of Module 1 compiled
100+
Markets where we have compiled Module 1