Drug Product Support

• Method development and validation

• Development stability

• QC testing

• In-process testing and manufacturing support

With decades of experience in the analytical chemistry of pharmaceutical development, Ricerca is the ideal development partner. We have the facilities and expertise to perform the full range of analytical support needed — including the entire CMC submission package — for INDs and NDAs. Skilled scientists offer the breadth of analytical capabilities and on-site instrumentation to handle both inorganic and organic substances; to do physical as well as chemical characterizations; to develop and carry out cGMP specification testing; and to perform stability studies and impurity identifications.

Method development and validation

• Specification testing

• Impurity profiles

• Bioavailability indicators

• Assays, including stability indicating tests

cGMP QC testing

• Release testing

• Raw materials testing

• Process and cleaning validation

• Specification development

Stability testing

• Full complement of ICH storage stability studies

• Photostability determination

• Freeze/thaw and high/low temperature stability studies