Ground Zero Pharmaceuticals, Inc. (GZP) focuses on bringing medical product programs through the FDA regulatory process, from late discovery through final approval and postmarketing. GZP’s philosophy of doing “what is necessary and sufficient and no more” at each stage of development aids clients via clean, cost-effective, targeted and accelerated development plans. With emphasis on completing each portion of a product's lifecycle in a rapid and resource sparing manner, while maintaining acceptable quality for FDA review, GZP adds value to our client programs by enabling accomplishment of important milestones.
External link for Ground Zero Pharmaceuticals
100 Spectrum Center Drive
Irvine, California 92618, US
Ground Zero Pharmaceuticals reposted this
Now available: FDA CBER’s Office of Therapeutic Products has released a new draft guidance with answers to frequently asked questions and commonly faced issues that arise during the development of cellular and gene therapy products. Review the draft guidance and submit comments by February 18, 2025. https://bit.ly/40Xerv4
Ground Zero Pharmaceuticals reposted this
FDA has published a batch of product-specific guidances (PSGs), including new PSGs for medications that treat diseases and conditions such as pulmonary hypertension, schizophrenia, atopic dermatitis, certain cancers, and others: https://lnkd.in/dBpZN4P When finalized, PSGs reflect FDA’s current thinking for developing generic drug products and generating evidence to support FDA approval of these products.
Ground Zero Pharmaceuticals reposted this
Providing small business owners with an array of business development, management, and marketing services to support the growth of their brand and online presence.
Evan Siegel provided some great insight on, "You're pitching a risky new product idea to your team. How can you effectively sell its value proposition?" Evan Siegel - "Provide a careful balance between the known data and the unknown, particularly when dealing with biological systems/products. Do not overinterpret positive information and diminish the importance of negative data. Share credit for the new concepts and ideas if warranted; never take redit for a new idea when it is not fully yours. Bring the team into an assessment of benefits and risks when dealing with a new product idea." Ground Zero Pharmaceuticals
Ground Zero Pharmaceuticals reposted this
Providing small business owners with an array of business development, management, and marketing services to support the growth of their brand and online presence.
Great welcome reception last night at #Stockholm City Hall to kick off #BioEurope. #pharma #biotech #lifesciences
Ground Zero Pharmaceuticals reposted this
Providing small business owners with an array of business development, management, and marketing services to support the growth of their brand and online presence.
Looking forward to #BioEurope next week! PM me if your program has any development needs! #regulatoryaffairs #FDA #biotech #pharmaceutical #productdevelopment #startup #lifesciences #clinical #clinicaldevelopment #preclinical #medicalwriting #CMC #eCTD
Evan Siegel is presenting, "What Makes For a Good Elevator Pitch to Investors?" Make sure to attend on October 22.
Tis the season for some great life science conferences! Evan Siegel dives into what investors are looking for during presentations and pitches. "This presentation will cover a number of the critical data, regulatory interactions, and investor-attracting elements that can lead to success" - Evan Siegel Join us on 10/23 (Sydney) - 10/22 (US)
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Tis the season for some great life science conferences! Evan Siegel dives into what investors are looking for during presentations and pitches. "This presentation will cover a number of the critical data, regulatory interactions, and investor-attracting elements that can lead to success" - Evan Siegel Join us on 10/23 (Sydney) - 10/22 (US)
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🧪 Heading to BioEurope in Stockholm? Let's Talk About Your Program's Development Needs! 🔬 If you’re ready to accelerate your program’s success, let’s connect at BioEurope. Lauren Mages is available for meetings—drop a comment or DM us to schedule a time. ✅ Regulatory Strategy ✅ Preclinical/Clinical Consulting ✅ Medical Writing ✅ Pre-IND - IND Submissions & Planning #BioEurope #Biotech #Pharma #LifeSciences #RegulatoryAffairs #ClinicalTrials #FDA
Ground Zero Pharmaceuticals reposted this
FDA announced over $5.4 million in new funding to support clinical research for rare neurodegenerative diseases: https://lnkd.in/eFax7JpA
Ground Zero Pharmaceuticals reposted this
Discover what the future holds for the pharma industry as we explore the shifting dynamics of the orphan drug market and discuss detailed insights into the sales forecasts of rare disease treatments expected to hit nearly $270 billion by 2028.