Category: Regulatory

Regulatory, Regulatory Submissions

Need help with your IND or IMPD?

The Investigational Drug Application (IND) and Investigational Medicinal Product Dossier (IMPD) mark a major milestone for drug candidates – namely, the ability to begin human clinical trials in the US or Europe, respectively. Creating a complete application that can satisfy the regulatory agencies is a substantial undertaking, requiring the input of Subject-Matter Experts from many areas, including Chemistry, Manufacturing and Controls (CMC), Drug Metabolism and Pharmacokinetics (DMPK), Toxicology, Clinical Operations and Strategy, and Regulatory Affairs. Coordinating the IND effort requires an understanding of how each section of the dossier supports the overall submission, the necessary content and level of detail required, and how to address limited data on the investigational drug at the time of submission.

With over 25 years’ experience in authoring, reviewing, coordinating and submitting INDs and IMPDs, we can guide your company smoothly through the planning, writing, review and submission of your IND and/or IMPD. If you haven’t yet had a Pre-IND Meeting with FDA, we can help you request the meeting, define the questions to be asked, and prepare the briefing document in advance of the meeting.

If you need assistance authoring CTD Module 1 (Region-specific Administrative Information), Module 2 (Overall Summaries) or Module 3 (CMC), we can help with some or all of the necessary module creation. We can also assist SMEs in creating Module 4 (Nonclinical) and Module 5 (Clinical), including review and formatting of each module.

If you’d like to discuss how E4 Consulting can facilitate your successful IND or IMPD, please contact us.

Regulatory, Regulatory Strategy, Regulatory Submissions

How we can help you reach the IND and beyond

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.