Our services
BioCell Therapeutics provides a wide range of professional consulting services to meet the needs of your biopharmaceutical or cell therapy development needs. We promise to provide solid guidance that balances a technical, quality, compliance, and regulatory risk-based approach to support development, commercialization, and launch.
Data Driven and Patient Centric
CMC Strategy Development
Crafting comprehensive Chemistry, Manufacturing, and Controls (CMC) strategies tailored to each client's unique drug development, supply chain, control strategy, and commercialization needs.
Product Quality Assurance
Implementing robust Product Quality systems, ensuring compliance with regulatory requirements and optimizing quality control and assurance processes.
Regulatory Filing Strategy
Assisting in the strategy, preparation and critical review of regulatory filings, briefing booklets, clinical and commercial submissions, responding to health authorities, and navigating inspections from regulatory agencies worldwide.
Technology Transfer
Providing expertise in technology transfer, comparability studies, process validation, and ensuring seamless transitions from development to commercial manufacturing.
Control Strategy
Developing integrated control strategies taking into account meaningful in-process, release, and stability specifications and control strategies.
Training and Workshops
Conducting specialized training programs and workshops to enhance internal teams' understanding of CMC and Product Quality principles.
Interested in our services? We’re here to help!
We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help.