With over thousands of methods developed, validated, and/or transferred supporting IND/ANDA/NDA/BLA applications, Nitto Avecia Pharma Services’ scientific team has a proven track record with nearly all drug forms, substances, and products.
Nitto Avecia Pharma Services’ analytical development group has experience in support of various dosage forms within the generic and branded pharmaceutical industries. The team’s diverse background has enabled Nitto Avecia Pharma Services to develop an in-depth understanding of all facets of the drug development process. In addition, Nitto Avecia Pharma Services offers extensive experience in gap analysis and remedial validation of existing methodologies to comply with current CDER/ICH guidelines for validation.
As development partners, we design detailed protocols for method development, validation, and technology transfer based on the products phase in the drug development process.