Successful Regulatory Strategies for Start-ups and Small Firms
Posted 01 October 2008 | By
The increasing costs of discovering and developing drugs and biologics often have a disproportionate impact on start-ups and small firms due to their often tight funding, "lean and mean" resource pool and intense pressure from investors to move ahead with greatest speed to meet milestones and, they hope, successful exit strategies. The key to dealing with these issues involves the generation of good data in the CMC, preclinical/nonclinical and clinical arenas and, most importantly, the establishment and execution of a sound regulatory strategy that ties together the data packages, integrates the data, and creates first-rate regulatory submissions, supported by sound, realistic regulatory strategy. The following approach may be helpful to such firms in improving the success rate of healthcare product development.