Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Medical Doctor with Expertise in all Phases of the Drug Development Process, Including Medical, Legal and Policy Issues Related to Pharmaceuticals, Devices, and Dietary SupplementsAll phases of the drug development process, including medical, legal and policy issues related to pharmaceuticals, devices, and dietary supplements.Therapeutic areas included asthma, epilepsy, cancer, cardiovascular disease, infectious disease, sleep, depression, and prostate cancer.Drug development initiatives, protocol development, data analysis, review and revision submission materials and manuscripts, safety data review, medical monitoring, and medical review...