Formulation Development and CTM Manufacturing

Expertise in a wide range of dosage forms

Laboratory Services
Product Development
Clinical Services
Applications and Solutions

Formulation Development and CTM Manufacturing

Frontage’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.

CMC CTM 1 300x200 - Formulation Development and CTM Manufacturing

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.

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