Clinical Trial Infrastructure

Over the years we have built a scalable drug development infrastructure that ensures quality control through a robust quality assurance program at every step of the development process, maintains redundancy of the development supply chain to mitigate risk and ensures flexibility in its operations to deliver speed.

Multiple Drug Master File Submissions:

Ananda Scientific has filed multiple Drug Master Files (DMFs) with the FDA to support the use of our investigation drugs in six FDA-approved clinical trials. These DMF’s describe the manufacturing and quality control processes we follow to ensure the top-tier quality and uniformity of our investigational drug products.

Compliance:

Resources and processes have been put in place to ensure regulatory compliance, demonstrating our commitment to meeting FDA standards.

Investigator Brochures:

Our Investigator’s Brochures serve as an essential reference document for our investigators, providing a comprehensive overview of our investigational products. It offers investigators a detailed insight into the formulation, pharmacology, and safety profile of our pharmaceutical innovations. With a focus on clarity and transparency, this brochure empowers our partners with the knowledge needed to conduct thorough and informed clinical trials.

Analytical Testing Validation:

Ananda Scientific has prioritized the development of fully validated testing methods for all phases of its investigational drug manufacturing and final clinical product release. These fully Validated Test Methods follow ICH Q2 guidelines, and FDA standards, and are an important component of ensuring our investigational drug product quality and reliability.