GMP Analytical Services

At Frontage, a highly-qualified team of scientists provides analytical services in support of your product development, as well as the chemistry, manufacturing and control (CMC) sections of your DMF, IND, ANDA and NDA filings. The Frontage team is experienced in analyzing a variety of dosage forms including oral solid, liquid, lyophilized, nasal spray, transdermal/topical and other products. Our chemists’ expertise includes chromatography (HPLC, GC, SEC, etc.), dissolution testing, atomic absorption, HPLC/MS, GC/MS, Karl-Fisher and titrimetric methods, among others.

 

Frontage is a FDA registered lab with a DEA license for controlled substance Schedules I-V.

 

Services

  • Material characterization

  • Compound log P and solubility

  • Method evaluation

  • Method development

  • Method transfer

  • Method validation

  • Formulation sample testing

  • Formulation stability

  • Forced degradation studies

  • Impurity identification and impurity structure elucidation

  • Complete compendial analysis (USP, EP, JP, BP, FCC)

  • API release

  • API stability

  • Reference standard qualification

  • Cleaning validation

  • Finished product release

  • Finished product stability

  • Marketed and clinical release

  • Comparator product testing

  • OOS investigation

  • Gap analysis

  • Trend analysis

  • Clinical dose strength verification

  • Clinical dose strength stability