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Alberto J Pacheco

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I am a creative problem solver, providing regulatory compliance and strategy services that prioritize risk mitigation and efficiently maximize available resources. A patient advocate at heart, I utilize real world experience to identify, design and implement custom solutions for high-priority needs. I lead biotech/pharma projects at all stages of drug development and regulatory submission pipeline, collaborating and effectively integrating with teams of all sizes. I have 18 years of experience in client-focused, GxP-regulated, regulatory (strategy/writing) and compliance operations. I am well-versed in auditing, gap analysis, continuous improvement, and inspection readiness to optimize sponsor oversight of Quality Management Systems (QMS), clinical sites/vendors, Trial Master Files (TMF), clinical operations, data integrity (21cfr11), and regulatory submissions according to best industry practices (ICH / ISO). I issue high level FDA, EMA, and ICH guidance to provide awareness and preparation for agency inspections. I am fluent in both English and Spanish and was born in San José, Costa Rica. Contact me directly to discuss present needs for a gap assessment of current systems, or to go over your immediate and long-term visions. Feel free to connect with me here as well to discuss industry standards, best practices, global biotech/pharma operations, regulatory updates, new therapies and approvals.

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