Overview

A biotechnology company developing a novel drug delivery mechanism, combining a unique drug-device technology for ultra-long release, partnered with G&L Healthcare Advisors to guide their regulatory strategy. 

The client required expert support in navigating the complex requirements for the U.S. Food and Drug Administration (FDA) classification, registration, and submission to maximize the product’s commercialization potential.

Challenges

The client encountered several regulatory challenges in developing and commercializing their drug-device combination product:
Regulatory classification and registration: The novel drug delivery mechanism posed significant regulatory challenges in terms of classification and registration with the FDA. The client sought to maximize the product’s value by aligning with regulatory pathways that could best support its commercialization.
Complex requirements for a combination product: Developing a clear regulatory strategy for a combination drug-device product with ultra-long release required careful navigation of CMC, non-clinical, and clinical requirements.
Timely submissions: The client required timely filing of their Investigational New Drug (IND) and Drug Master Files (DMFs) to support the development timeline of this breakthrough therapy.

G&L’s Approach and Solution

Working closely with the client’s internal teams, G&L ensured that all regulatory requirements were met, enabling the program to progress efficiently through:
Regulatory strategy and classification guidance: G&L provided strategic counsel on how to classify and register the novel therapy with the FDA. G&L guided the client on the most appropriate regulatory pathways to maximize the value of their asset and ensure compliance with FDA standards. G&L also advised on the presentation of the drug-device combination product to the FDA, detailing the necessary supporting data and the best approach for engagement with the Agency.
Content development and submission: G&L conducted the authoring and review of the CMC, non-clinical, and clinical components of the IND and Type II and Type V DMFs associated with the program. This ensured that all documentation was thorough and aligned with regulatory expectations. G&L managed the Electronic Common Technical Document (eCTD) publishing and submission services through the FDA’s Electronic Submissions Gateway (ESG), ensuring a timely and seamless submission process.

Impact and Outcomes

G&L’s involvement resulted in key positive outcomes for the client’s regulatory process:
Timely submission: With G&L’s strategic guidance and tactical support, the client successfully filed their IND and DMF on time, allowing for the continued development of their drug-device combination product.
Regulatory pathway clarified: G&L’s expert guidance helped the client confidently navigate the regulatory landscape, ensuring that the novel technology was appropriately classified and positioned for maximum commercial potential.
Ongoing partnership: The success of this engagement positioned G&L as a key regulatory partner, supporting the client as they continue to advance their innovative drug-delivery platform across multiple indications.