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). 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.

Pharmaceutical products are subject to high quality standards as part of submission for regulatory approval. Among these are: reporting adverse drug reactions; monitoring clinical trials and conducting inspections of manufacturers; compliance with good clinical practice (GCP); good manufacturing practice (GMP); good distribution practice (GDP), and good pharmacovigilance practice (GVP).

Manufacturers of pharmaceutical products are legally obliged to comply with good manufacturing practice (GMP). For their manufacture, distribution and marketing authorization, a manufacturing license is required. Therefore, for a drug manufacturer, the manufacturing authorization is a compulsory GMP requirement.

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 therapies (ATMPs).