Stolley Engineering is your technology partner for GMP engineering services for the biopharmaceutical industry and treatment centers for gene and cell-based therapy.
Welcome to Stolley Engineering
Stolley Engineering is a bioengineering company with expertise in GMP engineering for the biopharmaceutical industry and treatment centers for gene and cell-based therapy (ATMPs).
Our company specializes in validation and qualification for sterile manufactured biopharmaceuticals and gene and cell-based therapies (ATMPs).
Manufacturers of medicines for human or veterinary use, are subject to regulatory GMP requirements with regulatory authorities such as the U.S. Food & Drug Administration (FDA) or European Medicines Agency (EMA). They are legally obliged to comply with GMP. Manufacturing, distribution and marketing require a manufacturing authorization (MA).
Validation and qualification are essential regulatory GMP requirements. These are mandatory for customers when applying for manufacturing, clinical study, and marketing authorization with regulatory authorities. When we develop those validation and qualification strategies, we apply the “Lean GMP Validation Concept”. This helps us to follow refinement and reduction but keep to the regulatory expectations.
With more than 20 years of hands-on experience in GMP engineering, bioprocessing and biomedical research, we contribute expertise in analytical instrument and process equipment qualification, cell-based bioassay procedures, bioanalytical method validation, and quality control operations.
We guide you through your cGMP compliant manufacturing processes of biopharmaceuticals and gene and cell-based therapies (ATMPs).
“We believe that the innovation behind each new drug development starts with good manufacturing practice (GMP).”
Key GMP Services
Validation Services
- Analytical Method Validation
- Bioassays
- Process Validation
- Computerized System Validation (CSV)
- Cleanroom Validation (Annex 1)
- Statistical Analysis
Key GMP Expertise
- Manufacturing of biotechnological products
- Gene and cell-based therapy (ATMPs)
- Quality of Biotechnological Products
- Specification of Biotechnological Product
- Pharmaceutical Quality System
- Quality Risk Management
- Data Integrity and Computerized Systems
- European Commission’s Guide to GMP
- ICH Quality Guidelines
Your GMP Benefits
- GMP compliant manufacturing of Biopharmaceuticals and ATMPs
- Manufacturing authorization
- Clinical trial and marketing authorization
Stolley Engineering leverages their expertise on good manufacturing practice (GMP) to solve regulatory needs between customers and regulatory authorities