Ensuring Regulatory Success from Pre-IND Through to Submission

Preparing your strategic regulatory plan for your development program starts before and continues after preparing your Investigational New Drug (IND) application or Clinical Trial Application (CTA). As you look to transition your compound into clinical trials, you need the right partner to guide your planning and decision-making.

Our Regulatory experts provide regulatory guidance for product and program development through to the successful interactions with the FDA or other global regulatory agencies. Learn More >

Article: Early Development Challenges in IND Applications

Planning ahead whenever possible has the potential to provide a positive impact on INDs and their success rate. Learn how to overcome challenges in the pre-clinical stage of development and utilize best practices for excelling in the IND application process. Explore the non-clinical and clinical pitfalls and misconceptions of IND applications. Find out more >

Infographic: Shortening Development and Approval Timelines for Novel Medicinal Products

The FDA and EMA offer expedited regulatory approval pathways to accelerate the development of therapies intended to treat serious conditions and unmet medical needs. In this infographic, we highlight the benefits of 12 key special designations, many of which shorten development and approval timelines for novel medicinal products. Download >

Case Study: The Power of Publishing for an Efficient NDA Submission Process

The IND was transferred to us from another vendor and virtually all the content provided needed substantive review and modification to meet data submission requirements. Our successful regulatory consulting services on a previous engagement made our team a top contender for the company’s current need, and we were subsequently awarded this regulatory publishing assignment. Read more >

Event: The American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

Founder, President, and Chief Statistical Officer, John Balser, PhD, has been selected as a panellist and will be presenting in the scientific symposium: “Accelerate your Drug Development Program in Rare Disease with Robust Natural History Data: An Evolving Space” at 10:15 on Friday (5/19).

He is also a contributing author on the “Gene and Cell Therapy Trials in Progress” abstract that was accepted.

The ASGCT meeting takes place in Los Angeles, CA 16 May - 20 May 2023. Learn More >

Podcast: ART Podcast Regulatory Season

Season 3 of the Advancing Revolutionary Therapies (ART) Podcast is here. This season, we focused on regulatory topics that cover everything from smart regulatory strategies and maintaining continued regulatory compliance, to the influence of health authorities on clinical trials and more. Tune in to the series:

S3E1: Orphan Drug Designations and Orphan Subsets

S3E2: Emergency Use Authorizations

S3E3: Marketing Application Best Practices for Publishing

S3E4: CMC Pitfalls: From Benchtop to IND

S3E5: The Importance of Regulatory Project Management

S3E6: Regulatory Considerations for Biosimilars Development in the U.S.

S3E7: Considerations for Developing Rare Disease Treatments

S3E8: Apples to Apples: Playing the Comparability Game in Biotherapeutics Development

S3E9: The Influence of MDR's Article 117 in the Marketing of Combination Products 

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