Quality, Compliance & CMC Consulting
Quality, Compliance, and CMC Support for Every Stage of Development
BioEthica delivers tailored quality, compliance, and CMC solutions for companies at every stage – from startups developing their first drug or biologic to established firms with broad portfolios. Our expertise spans sterile products, parenterals, biologics, biotech, PET and radiological drugs, compounded medications, and small molecules.
We support manufacturing science and technology needs for product and process development, compliance, robust quality systems, quality program development, and strategic CMC planning.
Core Services Driving Quality, Compliance, and CMC Excellence
Quality Systems Design & Optimization
We build and remediate fit-for-purpose quality systems - tailored for FDA and EMA expectations. From documentation control to training and deviation management, we help you build a defensible, audit-ready foundation.
- Quality Organization Development
- New Quality Manager and Management Skills Assessments/Training
- Quality Culture Development
- Guide Development of Quality & Compliance Programs for Startup Companies
GxP Compliance Support
Full-spectrum support for Good Manufacturing and Good Distribution Practices, including gap assessments, vendor qualification, change control, and risk-based approaches aligned with ICH Q9 and Annex 1.
- Gap and Impact Assessments
- Vendor Qualification
- Root Cause Analysis
- Risk-based Approaches Aligned with ICH Quality Guidelines
CMC Strategy for Product & Process Development
We guide early- and late-stage product development through robust CMC planning - covering formulation review and enhancement, manufacturing processes, analytical methods, and regulatory dossier readiness for INDs, IMPDs, NDAs, and MAAs.
- Strategic Planning and Business Strategy
- Technical expertise in disciplines such as virology, biochemistry, microbiology, molecular and cellular biology
Inspection Readiness, Audit Support & Post-Inspection Strategy
Whether you’re preparing for a US FDA or EU (EMA, MHRA) inspection, we conduct mock audits, train your teams, and build confidence in your systems. We specialize in navigating quality system inspection technique-based inspections.
- Quality Systems
- Production Systems
- Engineering and Facilities – Fit & Finish
- Materials Systems
- Laboratory Systems
- Packaging & Labeling Systems
Regulatory Remediation and Inspection Readiness When It Matters Most
When your regulatory strategy is under scrutiny, we help you respond quickly and effectively with targeted solutions:
- FDA Form 483 Review & Remediation
- Warning Letter Responses & Corrective Action Plans
- Mock Audits & Gap Inspections
- Third-Party Audits for Due Diligence or Partner Vetting
- Pre-Licensing & Pre-Approval Inspection Readiness
- Data Integrity Risk Assessments & Remediation
- Field Alert Reports (FARs) and Biological Product Deviation Reports (BPDR) Investigation Support
Expert Support for Sterile and Aseptic Manufacturing
BioEthica helps sterile drug manufacturers uphold the strictest global standards for aseptic processing, cleanroom environments, media fills, and environmental monitoring – ensuring full alignment with FDA and EU Annex 1 requirements.
Diverse Product Knowledge
From biologics and small molecules to ATMPs, radiopharmaceuticals, and compounded preparations – we understand the nuances that affect quality, compliance, and regulatory success.
We work across the US and Europe with companies that value smart, phase-appropriate, scalable, and inspection-proof solutions. EMA-regulated companies increasingly turn to our former FDA professionals for strategic insight into US compliance expectations. Why?
US Market Access
FDA approval opens doors to the world’s largest pharmaceutical market - our expertise helps you get there faster and cleaner.
Inspection Preparedness
Former FDA specialists understand how regulators think. We anticipate their focus, prepare your teams, and strengthen your systems to withstand real-world inspections.
Global Alignment
With growing harmonization between FDA and EMA standards, partnering with FDA-experienced consultants ensures your systems hold up under both sets of rules. Change to: With growing harmonization between ICH Member Nations, partnering with FDA-experienced consultants ensures your systems hold up under scrutiny.
BioEthica translates FDA expectations into actionable strategies for RoW-regulated firms enabling them to expand globally with confidence.
building compliance from day one