Regulatory Consulting

Gain flexible staff capacity to meet regulatory milestones
With major milestones on the horizon, and new ones emerging in real time, regulatory teams often require specialized external resources to meet critical deadlines and manage peak demand. Klein Hersh can address your pressing functional needs and seamlessly augment your team, by providing access to experienced regulatory professionals on an interim staffing basis.

When your staff resourcing levels need extra support, Klein Hersh delivers the flexible capacity you require to fill specialized domain needs and hit your milestones:

Global Regulatory Affairs

  • Provide strategic regulatory affairs expertise to lead or support FDA and global market filings and health authority interactions.

Regulatory CMC

  • Lead or support filings of developmental or approved products.

Product Labeling

  • Address end-to-end labeling requirements via regulatory consulting expertise.

Advertising and Promotional Reviews

  • Offer technical knowledge and insight regarding advertising and promotional claims of drug, biologic, and medical device products.

Regulatory Operations

  • Deliver flexible capacity to outsource key functions and augment in-house staff.

Why Partner with Klein Hersh:

  • Leverage on-demand access to top regulatory talent.
  • Address short term staffing needs easily and cost-effectively.
  • Access flexible alternatives to full-time hiring.
  • Gain highly-specialized, technical expertise for complex projects
  • Fulfill compliance with evolving regulatory requirements.
  • Focus in-house staff on core growth activities