Early phase API discovery and development

Early phase API discovery and development is among the most challenging and exciting chapters of a molecule’s journey to market.

Increasingly complex chemistry and intense time and cost pressures can have a significant impact on your drug’s long-term success, potentially leading to project failure. The truth is that the decisions you make here and now have a tremendous impact on your molecule’s success when it reaches clinical trials and commercialisation.

So early-stage decisions must always be made in the context of the larger pharmaceutical lifecycle. One in two companies will outsource portions of preclinical research and development.  But the chances of a new drug making it to market are on one in 5,000. How can you maximise the chances your molecule will be the one?

The key is choosing a partner that understands the obstacles you face, and can help you overcome them one by one. Like the extensive research and development required for early phase projects, which a partner with strong analytical chemistry capabilities can help you carefully navigate.

Or time-consuming tech transfers, which can be accelerated dramatically by a partner that can handle your project requirements from A to Z.  And hazard evaluation, which can only be handled by a partner that can anticipate and prepare for new challenges that will emerge as your molecule scales.

Or earning funding support, which can be powerfully supported by a partner that commands credibility with a strong track record of success. And don’t forget IND applications, which demand a partner that combines regulatory and analytical expertise to compile the right supporting data.

The path to market always has its fair share of twists and turns, but the right partner can streamline this path through technical excellence, transparency and true scientific collaboration.

At Sterling, we are more than an outsourced vendor for API development. We are a PDMO^®, or partnership development and manufacturing organisation. That means we share in your mission to bring your molecule to market and are committed to positioning its journey for success from the very beginning.

Whether you’re a biotech start-up, an academic spin-out, or a promising new entity for a pharmaceutical leader, you can rely on our robust capabilities in analytical chemistry, product scale-up, hazard evaluation, regulatory guidance, funding support and much, much more.

Are you ready to get your molecule moving in the right direction with a different kind of outsourced partner?

Sterling. Service. Passion. Science.