05.13.25 -- Cell & Gene Therapy Regulatory And Compliance Solutions

Our integrated, end-to-end solutions enable launch success. Find broad and deep consulting expertise, flexible to meet you where you are in the journey from discovery through commercialization.

From rigorous inspections to adherence to BSL-3 and cGMP guidelines, a highly experienced QC Lead provides a detailed look at the critical role QC plays in guaranteeing the facility's integrity.

Cell therapy QC emphasizes the stability of preparation processes, multi-batch validation, comprehensive QC, and strict adherence to SOPs. Our solutions cover CAR/TCR detection, residual detection, and potency assays to ensure the highest quality standards.

Discover how our resources can streamline your documentation process, empowering you to achieve your goals with confidence. Delve into invaluable tips, and cutting-edge tools.

With our instrument qualification services, you can be confident that your instruments are installed, operating, and performing according to manufacturer’s specifications.

Novotech has been instrumental in the success of over 1,000 clinical trial projects in key areas such as immuno-oncology, infectious diseases, vaccines, and orphan and rare diseases.

The ClinicReady scientific and regulatory affairs process supports demonstration of safety and preliminary clinical Proof of Concept (POC) and lays the vital clinical foundations that ensures seamless transition into phase two and beyond.

Navigating the intricate global regulatory path is crucial for clinical development success. See how expert-backed support has consistently propelled sponsors toward regulatory excellence.

Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

PIMS (Process Information Management System) is 21 CFR Part-11 compliant, cloud-native software that creates a contextualized data backbone of critical manufacturing process and quality data across products and batches.