> Gens & Associates

“When Results Matter”

Gens & Associates helps all stakeholders in the regulatory eco-system improve their performance, ultimately shortening new drug approval timelines, increasing consumer access to information, and bettering medicine affordability. We do this through the combination of strategic leadership, informing / creating industry standards, and providing deep insights derived from our highly respected research platform to identify the most effective investments for improved outcomes.

What we do

We are a boutique Life Sciences management and organizational consultancy specializing in strategic planning and roadmap development, industry benchmarking, world class regulatory information management, organizational transition management, and working with leadership and project teams to accelerate change and value realization.

We regularly work with large and mid-tier global bio-pharmaceuticals, small growing biotech, medical device, consumer product, agricultural, regulatory software and service providers, and the investment community.

Our Benchmark Platform – Sharing for Impact We conducted our first study of technology innovations and ICH standard adoption in 2007 and 35 studies later, we are in the middle of the regulatory eco-system and relied upon for strategic trends and operational best practices by all parties. We committed to industry and the providers that serve them to conduct regular, mutually beneficial studies with a simple goal; “Everybody Gets Better.”

Our globally recognized benchmarks provide valuable information to inform strategy and key decisions such as:

  • How do we evolve our systems, processes and organization with our growing work in emerging and secondary markets to streamline how work is conducted globally?
  • What are the latest technology trends and which ones are worth investing in?
  • How can regulatory service and software providers better align their products and services to support industry where they will be in 2 – 4 years?
  • What are the most effective ways to modernize our regulatory capability
    and program; what makes business and compliance sense?
  • How do we increase collaboration and information exchange with our 100 + local offices around the globe and key strategic 3rd party partners?
  • What are the key non-technology practices to improve our operating performance?

Steve Gens MSOD Founder and Managing Partner

For 2020, we have an outstanding Core Research Team comprised of global experts
in regulatory, industry standard bodies, technology application, and business process / organizational excellence.

We are extending our regulatory benchmark effort to include a deeper analysis of the vital connections with clinical, safety/PV, label management, R&D portfolio planning, and the supply release process.

The Value of a Membership

Starting in 2019, we introduced our Premier Benchmark Membership to select industry and provider clients. This program combines our advisory services and benchmarking capability to work with each individual organization, however the program is framed around “community learning.” With an “executive lounge” containing our private research and market reports, it’s a collaboration platform consisting of private learning webinars, global survey design events to collaborate and improve the data we collect, and private community debriefs on the latest research and thought leadership. We find that the collective will always learn and innovate quicker; this is why we strongly believe that innovation is a “team sport”!


  • 2005: Company Founded
  • 2007: First large study of industry focused on technology innovations and ICH standard adoption (eCTD) – 75% of the top 50 companies (by revenue size) participated
  • 2009: Follow-up study focusing on collaboration technology and third-party information exchange
  • 2011: Incorporated regulatory service and software providers into the benchmark practice
  • 2013: First global study on the value and status of Regulatory Information Management
  • 2014: Incorporated medical device, diagnostic, consumer, small tier bio-pharmaceutical into the benchmark practice
  • 2015: Worked with 31 organizations to create a Regulatory Information Management World Class Standard as part of the benchmark analysis
  • 2017: Recognized in the PharmaVoice 100 as one of the most influential and inspiring organizations
  • 2018: Extended benchmark to explore the critical interactions of regulatory with clinical, safety/PV, and manufacturing
  • 2019: Launched our Benchmark Premier Service
  • 2020: Extended benchmark practice to include agricultural, eye care, and vaccine organizations

Our research platform provides vital regulatory benchmark information and insights to the Life Sciences community consisting of sponsors, service and software providers, investment community, and health authorities. With 35 studies conducted to date, our primary goal remains the same; broadly share what we learn so “everybody gets better”.


Serving over 120 Life Science Organizations

Year Founded: 2015

Gens Associates

1105 Taylorsville Road, Suite #319, Washington Crossing
Pennsylvania, 18940, United States

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