E4 Consulting specializes in providing Pharmaceutical Development, Regulatory Affairs, Quality Assurance and Project and Portfolio Management expertise to biotechnology and pharmaceutical clients. We provide both strategic and operational assistance to companies that are bringing new drug, biologic and device candidates into clinical trials and to market.
Moving a research compound into human clinical trials is a daunting task. Regulatory requirements for Chemistry, Manufacturing and Controls (CMC) are complex, even for early human trials. Materials to be dosed in humans must be manufactured, tested and stored according to current Good Manufacturing Practices (cGMP), and this means extensive development work must be conducted well before the IND is submitted to FDA or other regulatory agencies. Drug substance characterization (preformulation), formulation development, prototype manufacturing, analytical methods development and validation, stability testing and packaging selection are all necessary steps to a successful IND. Selecting one or more suppliers to provide drug substance and drug product manufacturing and testing activities is also complex, and often where virtual companies have the most difficulties.
We provide guidance and hands-on assistance with evaluating, selecting and managing contract research and manufacturing organizations (CRMOs) for drug substance (small molecule and biologics) and drug product (oral, topical and parenteral) activities. We have over 25 years’ experience in working with most major and niche CRMOs in North America and Europe, as well as many of the well-known Asian offerings. Partnering with CRMOs is definitely not a turnkey activity – keeping CRMOs on track technically and timewise requires active management and input in response to unexpected technical hurdles.