New Collaboration offers broad range of Compliance-and Risk Management Strategies in Europe and US to Life Science Industry
Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC – a leading Compliance and Ethics solutions consultancy based in the US – and NDA Group – a world leading integrated regulatory/drug development consultancy are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
Fabiana Lacerca-Allen, President of Ethiprax LLC commented:
“As we are intimately familiar with compliance requirement both in the US and Europe, we are able to help clients develop and maintain effective cultures of compliance. Too often companies hire one firm for US and another for EU and fail to implement a compliance culture across the entire organization. This collaboration offers a single partner who can provide global solutions.”
Johan Strömquist, CEO of NDA Group commented:
“We recognize that life science companies operate in different regulatory environments but fundamentally they all need to implement global best practices to maximize their opportunities for success. This is where we can add tremendous value. Doing the right things right doesn’t just feel good – it is the optimal way to create value.”
“Together with Ethiprax we extend the reach of our services and our geographic foot print on the US west coast – much in line with our growth strategy. This continues to bring the experience biotechs and pharmaceutical companies need closer to where they are.”
The NDA Group and Ethiprax collaboration will focus primarily on the following:
- Assess regulatory compliance readiness in early stage programs.
- Provide strategic assessments of emerging compliance needs, review existing programs and provide advice regarding best practices to optimize critical business processes.
- Align diverse teams to support manufacturing, clinical and product safety reporting requirements to connect the dots in compliance program development and implementation.
- Offer compliance assurance program design, policies, procedures and program execution.