• Advise on Regulatory Strategy: regulatory roadmap, module 3 Chemistry, Manufacturing, & Controls (CMC).
  • Advise on key early engagement meetings such as Quality Innovation Group (QIG), INTERACT, and Type D meetings.
  • Accompany you in key meetings with regulators, writing and review briefing Documents and Presentations for FDA/EMA/Competent Authorities Meetings.
  • Provide strategic information from our regulatory thought leaders.
  • Support filing of Drug Master Files (DMFs).
  • Publish files to FDA/EMA in eCTD format.
  • Enable “white label” and OEM manufacturers, providing FDA FURLS support.
  • Provide strategic information from our regulatory thought leaders.
  • Publish files to FDA in eCopy format.

Regulatory consulting and writing support

We offer comprehensive regulatory consulting and writing support services to guide our clients through the intricate approval process. Receive consultations and specialized writing services from our regulatory team to cover essential checkpoints including chemistry, manufacturing, and controls (CMC). We have experience with application types including IND and BLA submissions, and designations like Fast Track and Breakthrough Therapy. We'll help you streamline approval, de-risk milestones, and ensure global submission compliance.

Regulatory strategy and roadmap design

Let our team aid in regulatory strategy and roadmap design. We tailor our approach to the unique regulatory pathways of each therapy so you get timely, cost-efficient studies, and reduce the risk of IND rejection. Services include strategic planning, identifying suitable pathways within the NDA, BLA, and Marketing Authorization Applications (MAA), defining key milestones, optimizing document filing, exploring special designations and coordinating formal meetings.

Meeting support

We provide essential meeting support services to guide you through the regulatory milestones of each pathway. Services include: Timely meeting scheduling, request submissions, briefing package, documentation writing support, and accompaniment in essential FDA, European, or international meetings. This support covers a range of meetings, from early to late stage, and emphasizes appropriate selection and timing.

Investigational new drug (IND) application support

Need IND application support to guide your therapy from discovery to clinical trials? The IND package covers regulatory consultation, meeting, submission file preparation and publishing. Work with a dedicated and experienced team to streamline the most time consuming and tedious aspects of clinical trial applications.

Designation and special program applications

We excel in designation and special program applications. We’ll assist you in developing a comprehensive regulatory strategy for each step of the pathway, aiming for successful and well-managed approvals. Our team has experience with options like Orphan Drug Designation (ODD), Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, and Regenerative Medicine Advanced Therapy.

IND/CTA/MF amendments

Our team will assist you with IND/CTA/MF amendments and the intricate process of updating regulatory submissions. If you come across protocol modifications, changes in investigators, or information amendments it is necessary to have swift reporting to prevent disruptions in clinical trials. With global expertise and a customer centered approach, we facilitate efficient communication and expediate regulatory steps while minimizing risk.

Electronic common technical document (eCTD) publishing

We offer eCTD publishing services at key regulatory stages, such as IND and BLA/NDA submissions. Let us handle the formatting, cross-referencing, and document management of eCTD publishing. This service is particularly beneficial for small to medium-sized businesses because it eliminates the need for in-house electronic document management systems. Our eCTD services cover applications including documents, IND applications, ODD, NDA, and BLA, streamlining submissions across global markets.

Regulatory support, compliance, and validation files

Our regulatory support, compliance, and validation file services provide crucial documentation for therapy development and manufacturing, while supporting regulatory compliance.