Our Services
BioEthicA offers a menu of services, including, but not limited to the areas delineated below, applicable to Parenteral, Biologics, Biotechnology, PET and Radiological Pharmaceuticals, Compounding Pharmacy and Compounded Drugs, Small Molecule, Oral Solid Dose, Topicals, OTC, etc.
Development, assessment and advice for both clinical and commercial production with phase appropriate GMPs and oversight relevant to:
Quality and Quality Control
- Quality Management Systems
- Data Integrity Systems
- Complaint Systems
- Recall/Market Withdrawal Systems
- Reprocess/Rework
- Returns/Rejected Product Systems
- Deviation and Investigation Systems
- Corrective and Preventive Actions (CAPA)
- Out of Specification Systems (OOS)
- Change Control
- Training Systems
- Internal/External Audit Program
- Validation Program review and assistance
- Field Alert (FAR) and Biological Product Deviation Report (BPDR) Systems
- Process Improvement
- Document Management and Control Systems
- Quality Assurance Systems
- Quality Control Systems
- Quality by Design
- Materials Systems
- Supplier/Material Qualification Programs
- Vendor Audit Programs
- Water, Gas, Utilities (clean steam, process air, etc.) Systems
- Laboratory Systems
- Method Qualification/Validation Programs
- OOS Procedures and Systems
- Stability Systems
- EM Programs
- GLP (non-clinical toxicological studies and design)
- Engineering and Facility Systems
- Cleaning & Maintenance System Review and Support/Cleaning Validation Review
- Facility Layout Review and Support (air handlers, room classifications, HEPA, utilities)
- Sanitation & Pest Control Systems
- IQ, OQ, PQ/Validation Plan Reviews
- Contamination Control Systems
- WFI Systems
- Industrial Sterilization & Washing Systems
- Production Systems
- Aseptic Practices & Systems
- Prevention of Objectionable Organisms
- Master Batch Record System Reviews and Development
- Validation Systems
- Establishing Specification and AQL/LTPD Systems
- 100% Parenteral Vision Inspection Systems and Personnel Qualification
- Gowning Systems
- API Systems
- Packaging and Labeling Systems
- Qualification of Packaging and Labeling Systems
- Label and Packaging Control Systems
Compliance
- Audit and Post Health Authority Inspection Initiatives
- Data Integrity Observations
- FDA Form 483 Review and Response/Remediation
- Warning Letter Remediation
- Pre-Approval Inspections
- 3rd Party Audits
- Mock Audits
- Gap Inspections
- Risk Assessments/FMEA
- FARs/BPDR
Regulatory Strategy
- FD&C Act Compliance, Law and Evidence
21 CFR parts 11, 45, 56, 58, 200-211, 312, 314, 600-680, 820, 1271 & 45 CFR part 46 - GxP
- World Health Organization (WHO) Water Standards
- WHO Guidelines for Stability Testing and Climatic Zones
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- European Medicines Agency (EMA)
- Chemistry Manufacturing and Controls (CMC) Section Quality Reviews
- Labels and Labeling Review and Strategy
- Process Validation Strategies (large and small molecule pharmaceuticals)
- Non-Clinical Study Review
- Post Approval Change Strategies
- Post Marketing Safety/Evaluation Programs
- Adverse Event Reporting System (AERS)
- Risk Evaluation and Mitigation Strategies (REMS)
- Post-marketing Adverse Drug Experience (PADE)
Leadership
- Quality Organization Development
- New Quality Manager and Management Skills Assessments/Training
- Quality Culture Development
- Operational Excellence application to Quality Systems
- Human Capital/Personnel Development and Empowerment