Regulatory Consulting & Contract Staffing

Reach Milestones and Stay Focused on Growth

In today’s rapidly changing life sciences environment, it’s tougher than ever for regulatory organizations to keep pace. Evolving health authority requirements, challenging compliance demands, and shrinking submission time frames exert ongoing pressure on companies of all sizes – from growing market leaders, up to the largest, most established organizations.

How will you stay on track to meet your regulatory goals?

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.  This is where Klein Hersh Consulting can help. We can address your pressing functional needs and seamlessly augment your team, by providing access to experienced regulatory professionals on a contract basis. When your staff resourcing levels need extra support, Klein Hersh delivers the flexible capacity you require to hit your milestones, while keeping your in-house professionals focused on strategic, growth-oriented functions.

Leverage World Class Regulatory Talent, Efficiently and Cost Effectively

Klein Hersh is ideally-suited to meet your regulatory consulting and contract staffing needs. Our deep relationships in the regulatory professional community, honed through nearly 20 years in executive search and staffing, provide us with substantial reach to highly-skilled professionals. We tap our best asset – our unmatched talent pool – to efficiently and cost effectively deliver the quality resources you need to meet a broad range of domain requirements, manage non-core activities, bridge the gap during staff changes, or provide interim regulatory leadership. Klein Hersh can even assemble entire teams to tackle complex, longer-term requirements, while also providing support for multiple staffing assignments.

Proven Contract Professionals to Fill Specialized Domain Needs

Klein Hersh provides access to a flexible depth of talent to fill a broad range of critical functional requirements including:

Global Regulatory Affairs
  • Strategic regulatory affairs expertise to lead or support FDA and global market filings and health authority interactions.
Regulatory CMC
  • CMC expertise to lead or support filings of developmental or approved products.
Product Labeling
  • Regulatory consultants to address end-to-end labeling requirements.
Advertising and Promotional Review
  • Technical knowledge and insight regarding advertising and promotional claims of drug, biologic, and medical device products.
Regulatory Operations
  • Flexible capacity to outsource key functions and augment in-house staff.
Why Klein Hersh Consulting
  • 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.