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Strategic Alliance to support efficient, ethical practices in biopharma industry

NDA Group

New collaboration offers broad range of compliance-and risk management strategies in Europe and US to life sciences 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 recognise 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.”

Strömquist continues: “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:
  1. Assess regulatory compliance readiness in early stage programs
  2. Provide strategic assessments of emerging compliance needs, review existing programmes and provide advice regarding best practices to optimize critical business processes
  3. Align diverse teams to support manufacturing, clinical and product safety reporting requirements to connect the dots in compliance programme development and implementation
  4. Offer compliance assurance program design, policies, procedures and programme execution
About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Princeton, Boston and San Francisco. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional drug development services focusing on regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team of more than 150 full-time professionals is comprised of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies. NDA supported over 40% of the new medicinal products that were approved in the EU over the past four years. Visit: www.ndareg.com

About Ethiprax
Ethiprax is a specialized consultancy operating out of Hayward, California in the USA. Ethiprax was formed to help companies manage compliance and ethics risk. Drawing upon extensive experience related to healthcare-related organizations, Ethiprax helps clients develop and maintain effective cultures of compliance. Ethiprax brings industry best practices to the life sciences industry, ensuring that compliance requirements are addressed. Visit: www.ethiprax.com

Media Contacts
NDA: anna.perrin@ndareg.com
Ethiprax: clinton.allen@ethiprax.com

Eva Lilienberg
Left to Right: Clinton Allen, CEO, Ethiprax LLC; Fabiana Lacerca-Allen, President, Ethiprax LLC; Johan Strömquist, CEO, NDA Group
phone +46 (0)8 590 778 00
email info@ndareg.com
web www.ndareg.com/
email Oxford House Johanneslundsv. 2 S-194 81 Upplands Väsby
 
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