Compliance – The Competitive Differentiator to Commercialization: An Integrated Model Setting the New Global Standard

In their latest white paper, the Compliance experts at EVERSANA prove how integrated life science compliance has earned its seat at the table by demonstrating the value of increasing data-driven and technology-infused competitiveness in the successful commercialization of a new-age biopharma product.

Through the lens of an integrated pharmacovigilance, medical affairs, regulatory and quality team, the team outlines the challenges manufacturers face in bringing a brand to market; detail how the integration of services, process and technology leads to increases in safety and efficiencies; and stress the importance of moving compliance from a cost center to one of value and insight.

As part of EVERSANA’s commercial platform, they define how this holistic approach is fast becoming the new global standard of compliance that proves to be the competitive differentiator to commercialization.

Fill out the form below to download this 11-page white paper.

 

Author
Vikram Anand
Executive Vice President, Compliance Services

Vikram’s experience includes more than 20 years of leading global teams and building successful partnerships with top life sciences companies and health authorities around the globe. He has a strong background in digital technology and business consulting across R&D including drug safety, clinical research, and regulatory compliance and reporting, as well as a deep understanding […]

Author
Brandyn Abbott
Acting Vice President, Quality Consulting

Brandyn has extensive global quality experience in strategy, product development and life-cycle management of medical devices and combination products. His more than 10 years of quality and operations experience has involved responsibility from research and development to post-market with a significant number of small startups to Fortune 500 companies within the medical device, biologics, pharmaceutical […]

Author
Emily Becker
Director, Regulatory Affairs

Under Emily’s leadership, EVERSANA’s regulatory affairs consulting team has a proven record of providing successful global regulatory affairs support to clients in the medical device, pharmaceutical, biologic, combination product and tissue industries. With more than 10 years of experience in this field, she has authored and led: pre-IND meeting requests, INDs, Orphan Drug Designation, Fast […]

Author
Nina Patel Lahanis
Associate Vice President, Safety Science

Nina Patel Lahanis has a strong background in global pharmacovigilance, medical communications, regulatory compliance, medical education and technology. With 10+ years of pharmacovigilance expertise and more than 25 years in biotech/pharma R&D and marketing, Nina’s leadership expertise spans from the research lab to post-commercialization. Nina has led global drug safety operations, provided educational product training, contributed to new and organic […]

Author
Larry Davis, PharmD
Vice President, Medical and Clinical Affairs

Larry is a pharmaceutical and biotech industry professional with over 20 years of experience in the areas of medical and clinical affairs and drug safety pharmacovigilance, as well as in quality and regulatory compliance. He has a proven record of accomplishment in building and leading high-performing teams including those for office and field-based medical affairs […]

Author
Carolyn Quon, PharmD
Vice President, Medical Communications

Carolyn has nearly two decades of medical information call center, project management and client onboarding experience. Her focus continues to be on Medical Communications with a demonstrated track record of working successfully to support numerous clients in the pharmaceutical industry. Carolyn is skilled in U.S. Food and Drug Administration regulations, Medical Information Systems, performance metrics and KPIs, customer service, quality programs and call […]

Author
Lisa Rinker
Senior Director, Safety Science, Pharmacovigilance

Lisa brings more than 20 years of experience in pharmacovigilance operations and safety surveillance process development, vendor oversight and safety data exchange agreements to EVERSANA. She has expertise in the therapeutic areas of rare diseases, oncology and anti-infectives. Lisa began her career at Merck Research Laboratories and was responsible for the launch of the pharmacovigilance […]

Author
Thomas Barton
Thomas Barton
Senior Director, Business Process, Medical Communications and Pharmacovigilance

With more than 20 years of experience in information management, computer system validation and GxP system support, Thomas leads the business process team supporting regulated systems for medical information services and pharmacovigilance and has successfully implemented a state-of-the-art medical information and analytics platform to support the call center. Throughout his career, he has focused on […]