WMackin & Associates Inc Information

WMackin & Associates is a small, virutal Drug Development and Regulatory Professional Services company working with small and emerging Biopharmaceutical companies to enable successful IND submissions and initiate clinical development programs. Our core belief is that we utilize our extensive drug development backgrounds and experience to help bring new and complex therapies for human diseases into clinical trials. Led by Bill Mackin PhD, WMA is a group of seasoned drug development and regulatory professionals with extensive "hands-on"experience with the CMC and Pharm/Tox development of small molecules, biologics, cell based therapies and associated combination products. WMA also provides broad Project Management and US Regulatory services that include IND and medical writing services, ePub of regulatory documents for submission via the ESG, regulatory strategy development and execution and management of all levels of FDA interactions, including BLAs and NDAs. We have submitted INDs to all therapeutic area Divisions at CDER and the Offices of Vaccines and Tissues and Advanced Therapies at CBER. All of the INDs (>75) that we have submitted have been accepted for Review by FDA and INDs that we managed and written have recieved "May Proceed" decisions within the 30 day PDUFA mandated review period. We also have experience with electronic submissions of NDAs and BLAs, as well as providing technical support to these programs. WMA is very good at what we do and we work closely with Clients to insure that all projects are delivered with high quality, on time and at a reasonable cost.