Selkirk Pharma takes a proactive regulatory approach to promote continued success of our business and client experience. Our expertise across a range of regulatory disciplines – from compliance to operations to intelligence – ensures everything we do on your behalf advances your fill/finish manufacturing to market. This includes our facility’s compliance with new Annex 1 regulations for European markets as well as US FDA requirements.
When you’re this close to Phase 1, 2, or 3 clinical trials or to market, Selkirk Pharma keeps regulatory a highest priority for the success of your program.
Selkirk ensures compliance with all federal and state registration and reporting requirements for pharmaceutical manufacturing and testing operations. Additionally, we have deployed a comprehensive strategy to guarantee that Selkirk is registered in all state jurisdictions that require licensing of Contract Manufacturing Organizations (CMOs) to avoid unnecessary delay in our clients’ commercial US distribution.
Our immediate goal is to ensure clients a smooth, efficient, and successful submission experience when choosing to transfer a process to Selkirk. Our regulatory team has extensive Chemistry, Manufacturing, and Controls (CMC) experience specializing in manufacturing site transfers. We promote a long-term partnership with your team, so we can provide regulatory support as needed throughout the lifecycle of your products in all global markets.
Selkirk uses streamlined routine regulatory intelligence monitoring to remain up to date on the latest agency requirements and industry recommendations.