Investigational New Drug (IND) Application

An IND application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. It is required before a drug can be tested in clinical trials involving human participants.

Navigating the regulatory landscape for new drug development can be complex and challenging. Our comprehensive Investigational New Drug (IND) application services are designed to streamline this process, ensuring that your investigational drug meets all regulatory requirements for clinical trials.

Why choose our IND application services?

Expert Guidance: Our team of regulatory affairs experts has extensive experience in preparing and submitting IND applications to the FDA. We stay abreast of the latest regulatory updates to provide you with the most current advice and strategies.
Customized Solutions: We understand that each investigational drug is unique. Our services are tailored to meet the specific needs of your drug development program, from preclinical data compilation to clinical trial design.
Comprehensive Support: Our services cover all aspects of the IND application process, including pre-IND counseling, regulatory strategy development, document preparation, submission and communication, and ongoing regulatory support.

Key components of an IND application

a. Preclinical Data:

Pharmacology and Toxicology Studies: Detailed results of animal studies to demonstrate the safety of the investigational drug.

Pharmacokinetics and Pharmacodynamics (PK/PD): Data on how the drug is absorbed, distributed, metabolized, and excreted in the body.

b. Manufacturing Information:

CMC (Chemistry, Manufacturing, and Controls): Comprehensive information about the drug's composition, manufacturer, stability, and controls used during manufacturing.

c. Clinical Protocols:

Study Design: Detailed protocols for proposed clinical trials, including objectives, methodology, and statistical analysis.

Investigator Information: Qualifications and experience of the clinical investigators.

d. Additional Documentation:

Investigator's Brochure: A document that provides all relevant information to the clinical investigators conducting the trial.

Informed Consent Forms: Ensuring that all participants are fully informed about the trial and its potential risks and benefits.

Our comprehensive IND application services

Protheragen-ING Lab offers a comprehensive range of services to support clients in the preparation and submission of IND applications. Our services include:

Regulatory consulting	Provide consultation on drug registration regulation. Provide project evaluation and risk analysis. Design registration application strategy. Estimate project costs, plan project timelines, and ensure compliance.
Research service	pharmacology (API, formulation), pharmacodynamics, toxicology.
IND application	Pre-IND meeting preparation. CTD document review, translation, and preparation. IND document preparation and submission. Communication with regulatory agencies. Site inspection preparation. Management and tracking of the entire application process.
Project management	Guide project direction, progress, quality, and budget. Supervise study proposals to meet overall scope requirements. Organize phase reviews and prepare reports. Manage samples and documents to meet regulatory requirements. Manage outsourced collaborations.

Ready to take the next step in your drug development journey? Contact us today to learn more about our IND Application Services and how we can assist you in bringing your investigational drug to market.

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