We can help you design and implement your Stability Protocols, or you can use your existing protocols and analytical methods. The Laboratories stability protocols can conform to all elements of the ICH Guidelines for Stability. Specific zone requirements for all countries can also be accommodated depending on demand requirements.
GMP Clearance available for QC testing of raw materials, intermediates, bulks and finished packed product with TGA.
We can provide assistance in designing your Method Development Programs or can quote on the Methods you need developing or improving upon. Validation of newly designed or existing methods to meet global regulatory requirements is available also. ICH guidelines generally is used however specific country requirements can also be utilised for validation work.
We can provide assistance in the design of your Bio-equivalency Study and Clinical Trials and provide competitive quotations for this specialised Bio-analytical work. Our study area can facilitate 60 patients at any one time and the studies can be conducted in accordance with the Regulatory requirement of your target market. ADME studies including drug absorption, distribution, metabolism and excretion studies under doctor supervision.
Other areas of expertise include the analysis work for toxicology studies, drug release profiling for different formulations and Techmarking (which is essentially chemical comparison of an API or formulation against the innovator's or competitors' product for marketing purposes), and in-vivo studies.
Xena has highly qualified staff with extensive experience in the design of R&D programs which have led to international patents and commercialization of products and processes. We ensure that all Projects have pre-determined timelines and have rigorous Laboratory recording and Project reporting. As this topic is very comprehensive, we welcome all enquires and appreciate the opportunity to discuss your requirements further.
Regulatory approvals from TGA (Australia), MHRA (UK), RVO (EU), HMC (GCC), MOH (Oman).