How A Consulting Firm Can Assist Throughout The Investigational New Drug Process

By Antony Kaprielian and Isaiah Manoogian, PharmD

The Investigational New Drug (IND) application is a critical milestone in a drug’s journey toward a human clinical trial. A well-prepared IND ensures that all aspects of a drug — its pharmacology, toxicology, and manufacturing — are safe for human exposure. One of the most strategic tools available to sponsors is the FDA’s Pre-IND Type B Meeting, a free program that facilitates early engagement with the agency. These meetings help sponsors clarify study designs, align development strategies, and avoid unnecessary delays or clinical holds. They are especially valuable for novel therapies, unique study designs, and sponsors with limited FDA experience.

Pace Life Sciences offers full-service support for the IND process, from preparing and submitting the Pre-IND meeting request and briefing package to participating in the meeting and helping develop regulatory strategy. Pace also manages IND authoring and publishing, providing standardized templates, regulatory reviews, and final submission through the FDA’s Electronic Submission Gateway. Their team of regulatory, CMC, nonclinical, and clinical experts ensures comprehensive support tailored to each sponsor’s needs. Learn how Pace Life Sciences can support your drug development journey.