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Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time
There are several common mistakes in ANDA submissions that you can avoid to ensure speedy approval.
Learn what those mistakes are and what to do about them with the webinar CD and transcript set led by 30-year industry expert Dr. Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech.
He discusses the major changes occurring due to GDUFA … shares his experiences from working at the FDA … tells you what he's learned from hundreds of successful submissions of ANDAs … and finally, shows you how to avoid the 3 most common mistakes made in ANDA submissions — and ensure first pass approvals.
And that's just the beginning. You'll also get specific information and details regarding:
This is your chance to take away proven, winning strategies so your generic applications will never again have to be sent through endless FDA approval cycles.
Pharmaceutical companies and professionals looking to understand today’s increased US regulatory requirements for generic drug approvals in the US, the impact of the recent approval of GDUFA, and how to avoid deficiencies in your pivotal ANDA submission, particularly regarding the Quality and Bioavailability/Bioequivalence requirements. Including:
Dr. Andy Papas, PhD, MBA, RAC serves as the Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech. He has over 30 years of experience, including eleven years of regulatory experience at the FDA, nine years in the pharmaceuticals and biologics regulatory industry, and ten years as a research scientist. His areas of expertise include Regulatory Affairs, CMC, and marketing applications (NDA, BLA, ANDA, PMA, etc.) for a wide variety of pharmaceuticals, biologics and combination products.
NSF Health Sciences Pharma Biotech is at the leading edge of regulatory and compliance issues for the pharmaceutical, biologics and biotech industries. Its unique team of ex-FDA regulatory and inspectional professionals provides consulting that is authoritative and respected by major pharma companies and regulatory agencies around the globe. With subject matter experts in a broad range of pharmaceutical product types, including US ANDA submissions, NSF can provide expert advice across the product lifecycle, from development through registration and to technical transfer, manufacture and eventual discontinuation.
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