PPD Functional Service Partnership (FSP) Regulatory Affairs Solutions
Cross-Functional Experts Increase the Probability of Success
Creating and executing a regulatory plan that increases the likelihood of product approval requires specialized, customized, cross-functional expertise. To meet your evolving needs and proactively anticipate and overcome challenges, our cross-functional teams include a customized mix of roles. We employ a mix of senior staff members with long-running regulatory experience in the pharmaceutical and medical device industries along with regulatory professionals and chemistry, manufacturing & controls (CMC) specialists.
Each team of decision makers is empowered with the flexibility to provide solutions that meet your unique needs. A typical team may include:
- A regulatory oversight director accountable for strategic management of the portfolio
- A regulatory affairs lead as the primary client contact, who is accountable for development and execution of strategies and submissions
- And multiple other roles, as needed, to fill out the team, including regulatory specialists, regulatory country managers, regulatory assistants, or clinical and commercial roles
By bridging regulatory affairs knowledge with extensive clinical and commercial expertise, our team develops strategies that enable the most efficient registration pathways to maximize the probability of regulatory approval and fair market access.