Regulatory-as-a-Service: Innovative Bundling to Address Compliance Challenges

 

Life Sciences companies today are now realizing the need to address compliance challenges and evolving regulatory requirements, while pushing the boundaries for innovation and transformation within their own processes and systems.

But where do you to begin?

In this webinar hosted by Amplexor, industry leaders from Genpact will introduce an integrated, end-to-end Regulatory as a Service (RaaS) offering that leverages leading technical solutions, including Amplexor Life Sciences Suite and RIMExpert, available to the Life Sciences industry.

The new service blends Genpact’s strengths in regulatory product lifecycle management with established technology providers enables Life Sciences companies to take advantage of a unique, end-to-end proposition with full business process support.

With Genpact RaaS, sponsor organizations will be able to focus on critical aspects of bringing new products to-market while leaving the business processes and technology infrastructure support in the hands of a strategic partner.

Benefits of RaaS:

  • Speed-to-Value: Rapid set-up of full-service offering utilizing industry-leading, cloud-based pre-configured software
  • Limited Up-Front Investment: Deployment and other start-up costs are incorporated into the subscription
  • Flexible and Agile: Scale up and down as required for the customer's portfolio and needs change
  • Continuous Innovation: Leverages complementary digital transformation components, RPA deployment, workflow improvements, etc.
  • Reduced Operational Risk: Enhanced controls and analytics integrated into Six-Sigma engineered processes

By attending this webinar, you will learn:

  • What is RaaS and a detailed benefits review of an integrated end-to-end RaaS bundled solution
  • How an integrated, RaaS offering aligns with a holistic regulation information management (RIM) platform
  • How to deploy a more efficient and cost-effective platform to ensure regulatory compliance – despite the evolving regulatory landscape for Life Sciences companies

PRESENTERS

Rajiv Naidu – Business Leader Regulatory Affairs, Genpact

Rajiv brings more than 15 years of experience in Pharmaceutical R&D, Regulatory, and Digital sectors. He has comprehensive strategy and operations experience in advising top global Pharmaceutical companies, especially in leading large scale transformation programs, including mergers and acquisitions, Brexit, and Digital Transformation.

At Genpact, Rajiv leads the Regulatory Affairs practice globally and is responsible for driving profitable growth for the business. In addition, his role entails enhancing the go-to-market approach, actively pursuing strategic partnerships and acquisitions, building innovative offerings, and supporting critical client engagements.

Prior to Genpact, Rajiv spent more than ten years in the Management Consulting industry working for The Boston Consulting Group and Capgemini Consulting where he led multiple Corporate, R&D and Regulatory Affairs programs for Pharma companies.

Kevin Webb - Head of Regulatory Transformation Services, Genpact

With more than 30 years in the Pharmaceutical industry, Kevin has worked in Regulatory CMC at Wyeth and Pfizer – and other top ten healthcare companies. He has broad experience from his leadership roles in Quality, Manufacturing, Supply Chain, Technical, Regulatory, and Compliance.

In previous roles, Kevin managed critical regulatory Compliance initiatives and implemented global processes through the product lifecycle. He established and implemented global regulatory organizations, regionally based, focused on meeting the requirements of the regulatory authorities and improving the efficiency and compliance of new submissions and variations.

His extensive experience working with international regulatory Health Authorities and emerging markets has further positioned him to manage global submissions and simultaneous product launches in multiple countries

David Gwyn, Vice President, Life Sciences - North America, Amplexor

With more than 25 years of experience in the Life Sciences industry, David is a seasoned executive with extensive experience delivering solutions to clients, with a particular focus in the areas of content management and collaboration.

In his current role in the Life Sciences division of Amplexor, David’s primary focus is aligning customer needs with the capabilities of the company’s Life Sciences suite to ensure that the solution meets the needs of the customer.

David also leads the DIA EDM Submission Reference Model team, which has developed a document architecture for use when designing and building content management solutions. This architecture has been leveraged by numerous companies and vendors to provide submission management solutions that are compliant with global regulations.