GMP Compliance Consulting & Engineering Services

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 operations for sterile manufactured biopharmaceuticals and gene and cell-based therapies (ATMPs).

Pharmaceutical Industry & GMP

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 trial, and marketing authorization with regulatory authorities.

When we develop those validation and qualification strategies, we apply the “Lean GMP Validation Concept”, to avoid time-consuming retesting and documentation.

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.