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. We also provide direct hire recruitment services for a range of life science roles and functions.
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.
Looking to streamline your external project management and avoid rapidly increasing rates? Bundle your outsourced projects with The FDA Group through our Functional Service Program (FSP) engagement model for substantial discounts.
With our FSP, you get a single service provider for your projects and programs, reducing costs and complexity while receiving high-quality services from the industry's top talent.
Rather than coordinating a variety of projects with several vendors, you decide what you want to outsource to us to get rates that fit your budget, and we’ll provide all the necessary resourcing and external support you need at a discounted rate. With a single external support partner, you can more easily move and deploy the same resources across multiple functional areas, avoiding costs and delays due to additional onboarding and training.