DIA 23

May 3, 2023

Partnering for CMC Writing in New Drug Application

CMC writing is a standardized scientific and technical writing process to develop the documentation needed
May 1, 2023

Risk Evaluation & Mitigation Strategies: Needs, Challenges and Solutions

March 6, 2023

Establishing a regulatory roadmap for post-approval lifecycle management

A drug product transitions from different phases throughout its life cycle. The sponsors/applicants may outsource
September 30, 2022

Managing Seamless Transition and Establishing KPI driven Operations

Managing Medical information (MI) services in-house is a major challenge for any pharmaceutical company. Read
August 8, 2022
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Designing a Safety and Risk Management System for Cellular Therapies

January 12, 2021

Importance of Engaging a Safety Partner Early in the Drug Life Cycle

Ms. Jeanne Schow, Vice President & US Head of Business Development talks the key benefits