Discover the step-by-step roadmap to preparing and submitting your IND application. BioBoston Consulting provides expert guidance to navigate regulatory requirements for successful clinical trials.
From Concept to IND Submissions: A Detailed Roadmap to Regulatory Approval
The Investigational New Drug (IND) application is a crucial regulatory submission required to begin clinical trials for pharmaceutical/ biotech/ medical device companies. The following guide provides a detailed, step by step walk-through of the preparation and submission of an IND to comply with regulatory requirements and maximize the chances for success.
Step 1: Pre-IND Planning & Strategy
Host Pre-IND Meeting — Ask the regulatory agency (FDA, etc) for a meeting where you can discuss your development plans and proposed clinical trials and get feedback.
Regulatory strategy- Define a clear Regulatory strategy that meets the development goals for your product, incorporating special consideration of target market requirements.
Step 2: Preclinical Studies
Conduct Preclinical Studies: Perform detailed preclinical work to assess whether the drug is safe and effective by using animal studies and pharmacokinetics. These studies must Comply with GLP guidelines and generate reliable data.
Step 3: Investigator’s Brochure (IB)
Put together the IB: A full document on properties of a drug or product, and preclinical data (if any) with safety assessments, ready to be given to the Phase I Sponsors. Provide details such as chemical structure, pharmacology, toxicology, and relevant details.
Step 4: Chemistry, Manufacturing and Controls (CMC)
Generate CMC Data: Include an extensive drug manufacturing process, composition, specifications, stability, and quality control methods. Provide compliance to Current Good Manufacturing Practices (cGMP).
Stage 5: Preclinical Data Collection
Compile Preclinical Data: Collect and organize all applicable data from preclinical studies, such as study reports, protocols, and results. Maintain data quality, integrity, and compliance with the regulatory requirements.
Stage 6: Clinical Protocols and Investigation Plan
Design Scientifically Valid and Ethically Sound Clinical Protocols & Clinical Trials. Specify the study objectives, patient eligibility criteria, dosing protocol, endpoints, and statistical analysis plan.
Draft Investigational Plan that includes an overview of the investigational plan, with the population size, length of the study, locations where trials will be held, and mechanisms for safety monitoring.
Step 7: IND Compilation
Gather the IND Components: A full IND package includes an Investigator’s Brochure, CMC information, preclinical data, clinical protocols, and investigational plan
Administrative Information: Business Name, Contact Info and Authorized Signer
Step 8: Meeting Prior to Submission
Pre-Submission Meeting- Request to arrange a meeting with the regulatory agency to submit an IND and to answer any questions or concerns the agency may have.
Step 9: IND Submission
Cover Letter: Develop a cover letter detailing the contents of the IND submission as well as any other information relevant to the application
Submission Package Compilation: You gather all the IND parts, cover letter, IB, CMC data, preclinical results, and clinical protocols/plan into one document as your submission.
Your reference sample protocol will be submitted to the regulatory body. Submit to your specific regulatory agency in electronic or paper form as per their submission guidelines.
Stage 10: Review & Agency Coordination
One of your roles in the process is to respond to requests for agency input. The agency may want more information as part of their review. Respond quickly and comprehensively to these requests so that there are no hitches in the review process.
Continue communication – Keep the regulatory agency informed about your status, answer any questions that they may have, address their concerns.
Stage 11: IND Approval/ Clinical Trial Launched
Get IND Approval: If your application is successful, you need to wait for the regulator to approve you before starting trials.
Enrolling Patients: Begin enrolling patients in the trial under fully authorized protocols, and when all regulatory requirements are met.
The submission of an IND involves strategic planning, proper documentation, and adherence to regulatory standards. Following this step-by-step guide will help you to prepare an IND package that is coherent and increases the chances of regulatory approval
Conclusion
Do not forget to consult with regulatory experts like BioBoston Consulting for the relevant experience and complementary support required for a good IND filing.
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