1. NDA Development Plan

2. Text for New Drug Development http://www.wellcome.ac.uk/bigpicture/drug/ runflash2.html

4. NDA Registration Plan Mean EU approval time is approx 12 months Mean US ANDA approval time 10 months

5. Generic Development Plan A 10-stage development process to ensure rapid development and subsequent registration of generic applications Timescale: 18 to 36 months 1: Find out as much as you can about the brand that contain Active of choice and/or combination. 2: Gather as many examples of the branded OTC products or RX products containing active of choice from as many markets as possible and test them 3: Identify possible active ingredient manufacturers (AIM) - ensuring US and EU DMFs (Cert’s of Suitability) 4: Audit AIMs and identify appropriate source 5: Identify differences between existing product(s) and proposed product(s). Identify critical formulation parameters which influence above differences 6: Develop formulation (initiate validation of methods) Pre-screen toxicological and clinical performance if necessary –e.g., new delivery route 7: Develop/fine tune manufacturing process 8: Manufacture pivotal batches for stability/ toxicological data and clinical data 9: Clinical/bioequivalence studies, if necessary. Stability studies 10: Gather data and submit dossier

6. Generic Registration Plan Submission via DCP will usually take approx 15 months for Approval in all target EU countries Mean US ANDA approval time 18 months Mean Approval time in other International countries/regions 12 -48 months