Xania is a leader in the identification provision of Scientific Analysis, Research, Consultancy and Training to the global pharmaceutical, biopharmaceutical, healthcare and personal care sectors.
We understand how important it is for our customers to produce world-leading brands that are innovative, safe, of the highest quality, and meet the demands of legislation and consumers.
Xanias trusted expertise is delivered through our:-
- Investment in research & technology and people ensuring that we maintain our foundation in scientific excellence.
- Utilising multi-disciplinary teams.
- Our work with our esteemed customers to meet their needs for quick results, expert interpretation and sound advice.
- Our customer-focused, science-driven, result orientation that values performance, quality, respect, integrity and responsibility.
- Our strive to understand the needs, solve the problems and issues our customers face and by being proactive, flexible and innovative.
- And of course with the sole aim to deliver high-quality solutions and service.
We offer following Scientific Services to our esteemed clients.
- Pharmacopoeial analysis :
- We support our customers throughout the development and manufacturing process, ensuring product integrity from raw material to market via excipients and API analysis, batch release, product stability studies, and method verification or validation.
- Our scientists’ experience and detailed knowledge of the EP, USP, BP and IP methods enable us to provide our customers with dedicated support for pharmacopeial analysis.
- Stability storage management:
- In accordance with current Good Manufacturing Practices (cGMP) and International Conference on Harmonization (ICH) guidelines, we offer a comprehensive and cost-effective stability storage management and testing service.
- Our service includes a range of monitored temperature, humidity, and light stability storage conditions, covering for climatic zones I-IV. We are 21CFR-compliant and can store Schedule I-V controlled drugs. We are experienced in the development of stability indicating methods, including photostability and other stress condition studies.
- Whether it is only storage that is required or a combination with in-house analytical testing, we offer comprehensive project management, advice and support from protocol preparation to issue of final reports.
- Method development and validation :
- We specialize in method development and validation to support you with both Nutraceuticals and drug products through the entire product lifecycle.
- Our cross-laboratory, multi-disciplinary approach and experience of different dosage forms means we can guide and advise on the development of robust, fit-for-purpose methods appropriate for the specific phase of the development lifecycle. Our technical specialists offer a wealth of knowledge and advice on areas ranging from sample preparation and extraction techniques to regulatory aspects.
- Following successful method development, we can perform method validation in line with an approved protocol at a level that reflects the ICH requirements for the project type and stage of DP development.
- Microbiological analysis:
- Our expert team assists customers in ensuring the microbiological stability of their products, as well as demonstrating that they meet regulatory requirements.
- We perform microbial limits testing for specific pathogens, bacteria, yeast and moulds at all stages of the production cycle, from raw materials right through to finished products. In addition, we also offer preservative efficacy testing, challenge testing and environmental monitoring to fully the support the microbiological quality of products.
- Xania specializes in resolving chemical and physical contaminant issues in pharmaceutical and healthcare ingredients and finished products.
- Pharmaceutical industry Training:
- Our training are recognized and trusted as some of the best in the industry offering a highly interactive approach with pharmaceutical industry expert tutors.
- Our flagship Qualified Person (QP) training is carefully designed to focus on the knowledge requirements detailed in the latest Join Professional Bodies Study Guide with an emphasis on the practical role and duties of the QP.
- We also offer a range of other specialist consultancy covering areas such as Good Distribution Practice, Responsible Person, Good Manufacturing Practice, Auditing and many more