Obsidian Excellence Life Science Solutions
We are Scientist who know Quality, Regulatory Compliance, and Technology, and we are passionate about partnering with Pharmaceutical, Biotech, and Medical Device companies of all sizes to help them achieve their strategic business objectives. Our approach is simple but effective; we engage, learn and help you solve what matters. Our experts can support you during every stage of the exciting but challenging journey, of discovering, developing, and commercializing new medicines.
Satisfied Clients
Days Finding Solutions
GxP Learning Academy
GxP Training for Pharma and Biologics
GLP - Good Laboratory Practices
GCP - Good Clinical Practice
GMP - Good Manufacturing Practices
Data Integrity - ALCOA, ALCOA+
Deviation and Nonconformances
CAPA - Corrective/Preventive Action
Supplier Quality Management
GVP - Pharmacovigilance
21 CFR Part 11 Compliance
Computer Systems Validation (CSV)
Quality Management System Regulations, Standards, and Guidance
Biologics
CDER’s GCP BIMO Program
Pharmaceuticals
ICH E6: Good Clinical Practice
EMA Clinical Trials Directive
Pharmaceuticals and Biologics
21 CFR 211.192
Medical Devices
21 CFR Part § 820
Pharmaceuticals and Biologics
ISO 13485:2016
Virology
Pharmaceuticals and Biologics
FDA's New: Quality Management System Regulation (QMSR)
Immunology
Eye Care
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We engage. Learn. Then solve what matters!
Quality is Compliance
The concept of quality is at the core of many of our ideas about effective management and leadership, and programs like Total Quality Management and Six Sigma have been at the heart of many companies' success. Before things like globalization and technological advances became so important, competitive pressures were typically much lower, and companies were usually satisfied with focusing their quality efforts on the production process alone. Now, quality is often thought to start and end with the customer, and all points leading to and from the customer must aim for high-quality service and interaction. But to be truly successful, quality needs to be built into every level of a company, and become part of everything the organization does. From answering the phone to assembling products and serving the end customer, quality is key to organizational success.
