IMPD and IND-Enabling Packages
Capabilities
Streamline your path to IND and IMPD submissions with Pharmaron’s fully integrated IND-enabling services. Our global team of experts provides end-to-end preclinical and CMC development support, ensuring your drug candidate is ready for First-in-Human (FIH) clinical trials with a regulatory-ready package.
Key highlights from this service overview include:
- Comprehensive Preclinical Testing: From proof-of-concept to GLP toxicology studies, leveraging disease models across multiple species and administration routes.
- State-of-the-Art CMC Development: MHRA-approved GMP facility, scalable suspension culture manufacturing (15mL to 500L), and chromatography-based purification.
- Regulatory Expertise: Preclinical and CMC dossier authoring, stability testing, and regulatory interactions for scientific advice and pre-IND meetings.
With advanced bioanalytical capabilities, including NAb, ADA, biodistribution, and biomarker assays, Pharmaron provides a seamless transition from discovery to clinical development.
Download the service overview to see how our IND-enabling solutions can accelerate your program.