Product Development and CTM Manufacturing

Our team works to ensure a high quality product is produced for clinical trials.

pill formulationsFrontage’s formulation development and CTM manufacturing team designs formulations for targeted delivery of a therapeutic and then develops GMP manufacturing processes to ensure a high quality product is produced for clinical trials.

We develop finished products supporting IND, NDA filings and generic ANDA filings. Our facilities have been designed for flexibility, as we offer a variety of dosage forms and the ability to handle highly potent compounds and DEA-controlled substances.

Product Development
Fact:

Work with > 200 clients for > 200 compounds and > 380 GMP batches

  • IND: Formulation development and CTM manufacturing of oral solid, semi-solid (topical), liquid and sterile dosage forms
  • ANDA: Reverse engineering, formulation development and tech transfer
  • Consumer products: OTC reformulation
  • High potency suite for CTM manufacturing
  • Sterile suite for CTM manufacturing (Phase I)
  • DEA manufacturing license for controlled substances (CI-V)
  • Proof of Concept studies in animals
  • Integrated services with Frontage clinical center