IND-Enabling Chemistry

Once your preclinical candidate is in place, HIT2IND MedChem Consulting can support your scale-up, formulation, and GMP manufacturing needs and help your compound navigate through to IND filing.

6

Preclinical Scale-up Campaigns

Material for non-GLP and GLP toxicology studies.

3

GMP Campaigns

Drug Substance and Drug Product

7

Regulatory Filings

1 Full IND, IND and IMPD updates, DSURs, pre-IND Meeting Briefing Books

IND-Enabling Study Support

Chemistry doesn't end when toxicology begins! We can help with tox formulations, metabolite identification, analytical and bioanalytical methods, and report review.

CMC for Phase 1

From your GLP tox batches to GMP material for Phase 1, we can help select CDMOs and oversee Drug Substance and Drug Product manufacturing with a phase-appropriate approach.

IND Filing

Writing the CMC sections (Module 3) of your IND and help to review the entire filing.

IND-Enabling Chemistry Experience

Adding Value

Contact

Whether you have a request, a query, or want to work with HIT2IND MedChem Consulting, use the form below to get in touch with our team.