Services
Empowering Growth from Startup to Global Scale
The BioEthica team includes former US FDA regulatory and compliance professionals who bring a unique, insider-level understanding of what regulators look for – not just what the guidance says, but how it’s interpreted in real-world development and inspections.
This gives you a clear advantage:
Inspection-Ready from Day One
We don't just check boxes. We build your compliance and safety systems to withstand FDA, MHRA, EMA inspections, to name a few - because we've been on the other side of the table.
Risk-Based Thinking
Former FDA experts know how to apply a compliance mindset to Quality Target Product Profiles (QTPPs), Critical Quality Attributes (CQA), and Critical Processing Parameters (CPP), documentation integrity, and right first time, scientifically justified, decision-making credibility.
Higher Standards, Fewer Surprises
We apply the FDA's own Six-System Inspection Model and Quality Systems Inspection Technique (QSIT) principles to our client’s projects, ensuring your systems are traceable, controlled, and built for longevity.
Strategic Solutions, Not Just Task Support
We don’t just follow policies - we help you design them to meet FDA and EMA expectations. When guidance is vague or evolving, we interpret it with regulatory clarity.
Empowering Global Launches and Post-Approval Success
For companies preparing for global launch or scaling up post-approval operations, BioEthica provides more than just compliance – we deliver confidence.
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.