Learn all about our life science staff augmentation and project-based consulting services.
Finding and securing qualified, experienced life science professionals can be a monumental challenge. Our staff augmentation services offer a flexible alternative to traditional full-time hiring that enables you to connect with top life science talent through contracted resource placement.
Our quality professionals also perform detailed assessments of your existing quality system, identify current and potential problems, recommend corrective and preventive actions, and plan and conducting comprehensive remediation projects.
Our team of former FDA and industry professionals work hand-in-hand with pharmaceutical, biologic, and medical device manufacturers to uncover the root cause of compliance issues, remediate them, and implement the necessary measures to safeguard your reputation for quality both now and in the future.
We offer a team of Regulatory Affairs professionals who have vast experience working with the US FDA. Our regulatory expertise ensures that regulatory strategies and alternatives are considered at every step to help you gain product registration. We work with life science organizations in both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and carefully developed due diligence strategies.
Our experience encompasses US FDA clinical trial applications, and registrations of new chemical and biological entities, as well as those products containing established pharmaceutical ingredients (generics and 505(b)(2) products).
We develop high-level regulatory strategies to expedite products through clinical trials and into the market, and regularly represent our clients in meetings with the US FDA. We have experience managing the entire registration process for new medicinal products as well as for generic products. We have extensive experience writing Drug Master Files for product registrations and much more.