Our activity
There are four dimensions to AR2i's activity:
- Contract R&D: development and and validation of analysis methods, stability studies for pharmaceutical products, expert assessments for clients, in particular pharmaceutical laboratories and consultancy firms
- Stability testing according to ICH standards
- Marketing Authorisation: Drafting of drug registration dossiers, CTD module 3, eCTD, QOS and expert assessments
- Routine quality control: identification and assay of active ingredients and/or excipients, related substance testing, various physico-chemical analyses (pH, potentiometric titrations, osmometry,etc.)
Analyses are conducted in compliance with the protocols defined in the European Pharmacopeia. AR2i's laboratory can also adapt its work to its client's own protocols. In the remaining cases, the methods used are developed in-house by the R&D team.