Case study: Light Sciences Oncology Regulatory Compliance

Biopharmaceuticals & Life Sciences

Light Sciences Oncology Regulatory Compliance

Customer: Light Sciences Oncology

Project Location:Bellevue, Washington

Light Sciences Oncology (LSO) is developing Aptocine™ (talaporfin sodium) for solid tumors as well as other indications such as BPH. Aptocine is a water-soluble drug targeted by a small, single-use, disposable drug activator included with the drug. Aptocine is designed to provide tolerable, effective, and repeatable treatments for patients.

The Challenge

Light Sciences Oncology required FDA and European Union (EU) Chemistry, Manufacturing and Controls (CMC) documentation for their submission to the regulatory bodies for review and approval. This information is critical to the drug and device FDA and EU review process. It required a thorough understanding of the manufacturing and testing processes as well as understanding the drug substance and drug product regulations for both FDA and EU.

The Solution

Harris Group provided a broad range of regulatory expertise with over 30 years of experience in the industry of API, biologicals, medical device and advanced QC laboratory testing methods. Documenting, writing validation master plans and auditing commercial manufacturing organizations is a large part of our regulatory services. We combined the GAP analysis with current operations and compared them with the regulations to assure compliance at all levels.

The Benefits

Regulatory compliance requires a combined knowledge of manufacturing, facility requirements, test methodologies and the regulations to develop the right approach in solving complex issues to help our clients conform to the current good manufacturing practices. We have the operational experience as well as the knowledge to assist our clients through the rigors of FDA and EU documentation.

Harris Group Inc.’s regulatory team possesses a broad base of experience and knowledge from many years of owner side operational experience in many different situations. This experience helps our clients avoid the pitfalls of FDA and EU compliance while helping them build their own regulatory and QA team. We assisted in training programs both at the University level (http://biomedreg.washington.edu/biomedreg/) and at the company level. Harris Group was able to provide Light Sciences Oncology with the right regulatory resources to enable them to achieve their strategic goals.

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Overview Services Case Studies ...more White Papers Contacts	Light Sciences Oncology Regulatory Compliance Customer: Light Sciences Oncology Project Location:Bellevue, Washington Light Sciences Oncology (LSO) is developing Aptocine™ (talaporfin sodium) for solid tumors as well as other indications such as BPH. Aptocine is a water-soluble drug targeted by a small, single-use, disposable drug activator included with the drug. Aptocine is designed to provide tolerable, effective, and repeatable treatments for patients. The Challenge Light Sciences Oncology required FDA and European Union (EU) Chemistry, Manufacturing and Controls (CMC) documentation for their submission to the regulatory bodies for review and approval. This information is critical to the drug and device FDA and EU review process. It required a thorough understanding of the manufacturing and testing processes as well as understanding the drug substance and drug product regulations for both FDA and EU. The Solution Harris Group provided a broad range of regulatory expertise with over 30 years of experience in the industry of API, biologicals, medical device and advanced QC laboratory testing methods. Documenting, writing validation master plans and auditing commercial manufacturing organizations is a large part of our regulatory services. We combined the GAP analysis with current operations and compared them with the regulations to assure compliance at all levels. The Benefits Regulatory compliance requires a combined knowledge of manufacturing, facility requirements, test methodologies and the regulations to develop the right approach in solving complex issues to help our clients conform to the current good manufacturing practices. We have the operational experience as well as the knowledge to assist our clients through the rigors of FDA and EU documentation. Harris Group Inc.’s regulatory team possesses a broad base of experience and knowledge from many years of owner side operational experience in many different situations. This experience helps our clients avoid the pitfalls of FDA and EU compliance while helping them build their own regulatory and QA team. We assisted in training programs both at the University level (http://biomedreg.washington.edu/biomedreg/) and at the company level. Harris Group was able to provide Light Sciences Oncology with the right regulatory resources to enable them to achieve their strategic goals.