Our Focus and History

Founded in 2005, Gens & Associates Inc. is a Life Science benchmarking and advisory firm specializing in improving client performance, developing clear and pragmatic strategic plans and implementation roadmaps, and supporting organizational transition.

Our regulatory benchmark data is the industry standard – quoted by industry analysts, software and service providers, thought leaders and utilized extensively by industry.

Company Milestones

2005

Company Founded

2007

First large study of Regulatory focused on technology innovations and ICH standard adoption (eCTD) – 75% of the top 50 companies (by revenue size) participated

2011

Incorporated the 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

2016

Worked with 35 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

2019

Launched our Premier Membership Service

2020

Extended benchmark practice to include agricultural, eye care, and vaccine organizations

2021

• Expanded our benchmark scope to include Quality (R&D / Commercial)
• Recognized in Crosstree’s Innovations in Pharmaceutical Development as a top 55 innovator

2022

• Record participation in our World Class RIM Benchmark
• Membership grows to over 40 members

2023

Enrolled over 300 Local Affiliate Offices to participate in Global Regulatory Study

World Class RIM^℠
Over 100 Life Science Organizations have participated in our World Class RIM benchmark that provides the only industry peer comparison with the latest survey data on peer investments, process and organizational improvement plans, and the RIM Software and Services Provider Landscape. Whether you are modernizing your capability or rethinking your approach, our deep RIM strategy and planning services coupled with our regulatory knowledge and RIM benchmarks are unparalleled.
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Benchmark Premier Membership
We started our invite-only Premier Membership Program in the fall of 2019 that combines our strategic performance improvement advisory service, with access to our private survey content and market reports through our Executive Lounge.
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Steve Gens | Gens & Associates Founder

In the summer of 2005, I founded Gens & Associates Inc., a virtual consulting firm that serves the global Life Sciences industry. The office consisted of a folding table, chair, laptop and cell phone in a spare room of my home. Today it is a leading independent boutique management and organizational consultancy that provides advisory consulting services and a world-renowned regulatory benchmark serving over 100 Life Sciences organizations annually.

The company’s mission is to help all stakeholders in the regulatory eco-system accelerate global transformation, increase efficiency and organizational agility to shorten approvals of effective new drugs and contribute to medicine affordability. We do this through strategic leadership, enhancing industry standards, collaboration, and providing deep insights derived from our highly respected research platform, to identify the most effective investments for improved outcomes.

Words From Our Founder – Video