Licence In New Products

MRF & CTD DOSSIERS

MaxiPharma’s Person Responsible for Regulatory Compliance or ‘PRRC ’experts help you to clear all the hurdles on the journey to regulatory approval for existing or newly developed products. We support our customers with finding the most suitable registration strategy for the products we develop and manufacture. We involve our Regulatory Services team during the research and development phase to ensure that regulatory aspects are considered from the outset, and registration runs smoothly.

Our highly experienced pharmacists and chemists offer the following services for National (NL), Decentralized (DCP) and Mutual Recognition (MRP) Procedures:

• Compile up-to-date marketing authorization application dossiers in eCTD format (electronic Common Technical Document) for medicinal products.
• Plan and conduct Mutual Recognition Procedures (MRP) and Decentralized Procedures (DCP) and support with National Procedures (NL).
• Prepare all quality-related content of the application dossier for all MaxiPharma medicinal products in eCTD-compatible format (CTD Modules 1.4.1, 2.3, 3, and further supporting documentation for Module 1).
• cGMP (MCC/FDA/WHO/ICH) - Guidance and Auditing.
• Validation of Systems and Methods.
• Qualification of Equipment from DQ, IQ, OQ and PQ.
• Assessment and Validation of Purified Water Systems.
• Assessment of Cleaning Validation of Equipment.
• Product development strategies.

We will deliver your high-quality product as faster, cost-effectively, and getting your product to the market faster and keeping it there.