from Product profile to patient leaflet

Approvable, readable and patient friendly prescribing information is critical to the success of your product. The compilation of Product information is a specialized process. Compound properties and study outcomes determine a substantial part of the content of the product information. However, knowledge of regulatory requirements and comparable drugs is needed to make a crucial difference in the approvability and market value of your product.

The team at Zwiers Regulatory Consultancy has years of experience with labeling texts and regulatory intelligence. We can deliver:

• Target Product Profile
• Company Core Datasheet
• Summary of Product Characteristics
• Patient Leaflet

Doing justice to the potential of your drug while meeting regulatory requirements.

Maintenance and compliance

Zwiers Regulatory Consultancy offers the following specific services:

Annotated versions of the CCDS
justifying all claims of your medicinal product
Annotating the CCDS is a time consuming and burdensome task, especially for mature products. We take this task off your hands, freeing up your valuable resources

Labeling updates
reflecting changes in risk-benefit profile
We  incorporate new scientific insights, authority requests and outcomes of particular procedures (worksharing, Article 45/46)

Compliance checks
ensuring that all the changes are implemented
We perform thorough checks to ensure that safety labeling variations and procedure outcomes have been implemented in all labeling texts. 

If you need our help with any of the above, please contact us. We'll get back to you as soon as possible.