Strategic Regulatory Insight. Quality Without Compromise
BioEthica delivers expert consulting in quality, compliance, regulatory affairs, and pharmacovigilance - led by former FDA professionals and scientific leaders.
We help life science companies navigate complex global regulations with clarity, precision, and purpose.
Successfully supported over 200 regulatory submissions across FDA, EMA, MHRA, Health Canada, PMDA, and beyond – spanning biologics, small molecules, and combination products.
Our team includes former FDA investigators, inspectors, and reviewers who understand how regulators think - and what it takes to meet and exceed expectations.
Full Lifecycle Support
From early-phase development to post-market obligations, BioEthica provides integrated quality and regulatory solutions tailored to every stage of your product’s journey.
Global Regulatory Consulting for Life Sciences Innovation
BioEthica LLC is a global consultancy specializing in quality, compliance, regulatory affairs, pharmacovigilance, and organizational development within the pharmaceutical, biotechnology, and biologics industries. With deep expertise in life sciences and health authorities worldwide, we help companies navigate complex regulatory landscapes with confidence.
Our core services include FDA, EMA, and ROW eCTD (ICH) submissions, pharmacovigilance, and quality system support, including complaint handling and adverse event triage, adjudication, and submission. In 2025, we will expand into contract testing laboratory (CTL) services, method development, and assay validation – backed by former FDA officials and PhD-level experts. Few CTLs can offer this caliber of regulatory and scientific expertise.
We provide ethical, sustainable, and quality-driven solutions that protect brand integrity and ensure effective, scalable compliance through leadership and industry best practices.
Strategic Support Across the Product Lifecycle
Post-Market Pharmacovigilance
Ensuring patient safety through vigilant adverse event handling, medical inquiries, and product quality oversight.
Quality, Compliance & CMC Consulting
Quality and compliance, risk management, and robust, inspection-ready systems aligned with FDA’s Six-System Inspection Model.
Regulatory Affairs & eCTD Submissions
Expert guidance in regulatory strategy, authoring, and seamless submissions through FDA ESG and global health authority gateways.
Empowering Growth from Startup to Global Scale
With experience spanning industry and global regulatory agencies, we understand the needs of businesses from startups to global enterprises. Our tailored, phase-appropriate approach ensures right-sized solutions that evolve with your growth.
Partner with BioEthica for strategic regulatory excellence, quality efficiencies, and long-term success in life sciences.
Safeguarding Quality and Compliance Across the Product Lifecycle
BioEthica, LLC, is dedicated to safeguarding biologics, drugs, advanced therapeutic medicinal products, and combination products throughout their lifecycle.
Through a culture of quality and a commitment to quality by design, we collaborate with clients to deliver ethical, sustainable, and quality-driven solutions that uphold brand integrity and help foster a culture of quality and a commitment to quality by design.
By leveraging industry best practices and regulatory expertise, we ensure effective and long-term compliance, supporting success from early-phase clinical trials to commercialization.