As you might be aware of a couple of European Systems for obtaining the marketing authorization of medicines in Europe "The Centralized Procedure" via EMA valid throughout Europe. The Nationalized Procedures, Decentralized Procedure and Mutual Recognition procedures (EMEA) as per procedure is laid down in EU Directive 2001/83/EC and 2004/27/EC are the routine tasks for us. And most of the MRP applications have closed out with a positive approval at day 90 and DCP's at Day 120 means in Assessment Step 1.

We have hands on experience with all sort of applications like Generic [article 10(1)], Hybrid [article 10 (3)], Biblographic [article 10 (a)], Fixed Combination Products [article 10 (b)], Inform Consent [article 10 (c)]. 

We also opted for "scientific advices" (from SAWP) for waiving clinical trials and for Orphan designations for rare diseases for Centralized Applications during the course of development.

Current Work Responsibilities: 

We are in communication for the application of Conditional Approvals. We are dealing with few clients that are working on the "optional scope" to apply under Art 3 (3). We have loaded a few requests for "Line extensions" as well.

Apart from Initial Dossier submission (Module 1 to Module 5 ), we assist our clients during the Assessment phase By answering the LOQ List of Questions & List of Outstanding issues if any from the Agency to come out of clock stop period as soon as possible. We do take up Product Life Cycle Maintenance activities like Variation filling, Renewal Submissions.