Services
What we do...
From bench-2-batch, we deliver end-to-end CMC solutions that power your path to commercial launch. Whether it's characterization, scale-up, tech transfer, or validation, I turn complex science into regulatory-ready execution.
PPQ & Validation Solutions
Ready2Launch™ delivers comprehensive Process Performance Qualification (PPQ) and lifecycle validation support to ensure your product is prepared for commercial success. We partner with you to execute validation master plans, manage critical studies, and generate submission-ready documentation that withstands regulatory scrutiny.
Scale Up & Tech Transfer
From assessing facility readiness to generating GMP-compliant documentation, we offer a fully integrated service package that bridges process knowledge with execution precision. Our expertise ensures that your tech transfer, scale-up, and manufacturing documentation are scientifically justified, audit-ready, and fully aligned with your CDMO’s capabilities.
CPV & APQR
CPV-Pro™ delivers end-to-end support for establishing, maintaining, and continuously improving your Continued Process Verification (CPV) program. We design compliant, data-driven CPV strategies that ensure sustained process performance and regulatory confidence throughout your product lifecycle.
Stage 1 Process Characterization Consulting
Our Process-Char™ platform delivers expert guidance through Stage 1 Process Characterization—ensuring your process is scientifically justified, risk-based, and ready for regulatory submission. From identifying critical process parameters (CPPs) to developing a robust control strategy, we provide end-to-end consulting tailored to biologics and advanced therapies.