Gens & Associates
“When Results Matter”
“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:
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”!
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