Investigational New Drug (IND)

The Regulatory Affairs Department compiles all components of your Investigational New Drug (IND) applications, including nonclinical and clinical summaries, investigator brochures and updates. Leveraging our insight into the specific areas of drug approval and our successful track record of communication with the FDA, we expedite your original IND submission to accelerate the drug development process. Our highly qualified medical writers and regulatory staff apply the principles of good scientific and medical writing when preparing your IND documents, facilitating approval of applications to conduct clinical trials of new drugs.

Our IND associated goals and responsibilities typically include:

• Pre-IND and Pre-NDA meetings (briefing book preparation, meeting support and attendance, and regulatory strategy guidance).
• IND submission and maintenance (protocol submissions as IND Amendments).
• NDA submission supports.
• IND maintenance (submission and tracking of IND Safety Reports, Annual Reports, and Amendments).