Top-Flight execution starts at the top, with a portfolio-wide strategy and governance structure that can provide the decision-making and empowerment that all teams require in order to excel. Our extensive CMC experience can help us help you to craft a bespoke strategy and governance structure to ideally suit your portfolio’s needs.

Achieving high rates of manufacturing success at a reasonable cost is a key competency for any modern biotech company. Peregrine Bio offers a full suite of manufacturing strategy and operations support services ranging from development of a forward-looking supply chain strategy for both clinical and commercial products; facilitation of make vs buy manufacturing decisions; management of mfg facility design, construction, startup and validation projects; and helping you to select and then manage your CMO/CRO/CTL partners.

Taking a benchtop process through development and into a cGMP setting can be a daunting process, and ensuring a high-level of product quality is priority #1. With over two decades of cGMP experience, Peregrine Bio is here to help you establish phase-appropriate cGMP quality systems, perform cGMP audits of both internal and external facilities, labs or suppliers, and ultimately get your team PAI ready. With experience in North America, Europe and China, Peregrine Bio can provide the global quality perspective that your product vision demands.

We understand that there is no one-size-fits-all solution for taking a program from the research phase into, and through, development. Whether you’re working on a pre-clinical program, or one in late-phase human trials, Peregrine Bio has the subject matter expertise and experience to help you develop phase-appropriate solutions, integrating Quality By Design drivers with Design For Manufacturing considerations into a cGMP compliant, commercially viable development program.

The path from research, through development and to commercialization culminates in the preparation of your program’s regulatory documentation. Navigating the constantly-evolving regulatory climate can be a challenge. Peregrine Bio can help support both the development of your organisation’s overall CMC regulatory strategy and the preparation of CMC-related regulatory filings for individual programs.

Even the best strategy in the world can’t fully mitigate everyday execution risk. Peregrine Bio provides a highly-flexible, outcome-driven style of project management that is ideally suited for the iterative, non-linear, science-based projects that form the core of most biotech portfolios.