IND Enabling Services

The investigational new drug (IND) application is a major milestone in the life of your drug. According to the Food and Drug Administration (FDA), an IND submission must include animal pharmacology and toxicology studies, manufacturing information, clinical protocols and investigator information.

Through our site in Longmont, CO, 国家授权正规彩票平台 offers full CMC support for your IND application, from process chemistry and drug substance manufacturing all the way through formulation development and drug product manufacturing. Throughout the entire process, our analytical team provides quality analysis of your program to ensure you meet your milestones. With process chemistry, drug product and analytical experts collaborating under the same roof, we ensure that your molecule has its best chance at success.

To help you meet strict IND requirements and accelerate the filing process, we provide all supporting analytical data (specifications and release data) for raw materials, intermediates and APIs. We also provide all master batch records, as well as a certificate of GMP stating that we manufacture our APIs according to industry standards.

Our IND enabling services include:

  • Process chemistry
    • Synthetic process development
    • Scalable processes
  • Drug substance manufacturing
    • GMP
    • Gram to multi-kilogram scale
  • Pre-formulation
    • Polymorph/salt screening
    • Solubility/physical characterization
    • Excipient compatibility
  • Formulation development
    • API in bottle or capsule
    • Formulated tablet or capsule
  • Drug product manufacturing
    • Hundreds of thousands of dosage units
    • Packaging and labeling
  • Analytical services
    • Material characterization
    • Impurity identification
    • Method development and qualification
    • Release and stability testing