Regulatory Applications & Submissions

When choosing a Reference Member State (RMS) for a Decentralized Procedure (DCP) in the EU, consider RMS slot availability and the National Competent Authority's (NCA) experience with your type of application and product category. It's crucial to ensure the NCA has sufficient resources to meet your target timelines and avoid delays. Additionally, consider the financial aspects, including state fees for the RMS during the Marketing Authorization Application (MAA) and throughout the product lifecycle, to ensure cost-effectiveness.

To increase the chances of marketing authorization approval, we recommend conducting a thorough dossier gap analysis or due diligence before submitting your Marketing Authorization Application (MAA). This process identifies any deficiencies in your dossier, allowing you to address them proactively. Remediating these gaps ensures that your submission is robust, compliant with regulatory standards, and more likely to receive approval without delays. Engaging in this preparatory step significantly enhances your chances of a successful outcome.

To succeed in an Rx to OTC classification change, you need to ensure that the product is suitable for self-diagnosis, has a strong safety profile, and poses minimal risk for misuse. Sufficient post-marketing experience, appropriate packaging, clear patient information, and an easy-to-use dosage form are also critical. Thoroughly analyzing market conditions, local policies, and preparing robust clinical documentation can increase the chances of a successful switch. Engaging experienced professionals can further enhance your submission's success.

We have extensive experience managing various regulatory procedures, including the Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP/RUT), and National Procedures. Our expertise covers the EU/EEA region, the Eurasian Economic Union (EAEU), and international registrations through national procedures, enabling us to effectively navigate and secure approvals across multiple regulatory environments.

We have extensive experience with a wide range of product types, including New Chemical Entities and Generics, Biological products, Orphan Drugs, Combination Products, Well-Established Products, OTC and Herbal Medicines. This diverse expertise allows us to effectively navigate the regulatory landscape and support the successful development and approval of various pharmaceutical products.