Regulatory & Consultancy
Drug Development Expertise and Support
With more than 20 years as part of one of the top five global pharmaceutical companies, combined with 5 years working for one of the world’s largest CROs, the Arcinova team have a unique insight into drug development.
Our experts can work individually, collectively or as part of your team to assess data and recommend a path forward to achieve rapid drug registration, overcome problems or carry out due-diligence. Our agility and flexibility means we can embrace both small and large scale project challenges.
Our customers benefit from close one to one support and direct contact with our scientists, and whether you require advice in a particular area or a more integrated, holistic approach, we can help.
Prior to approving any clinical trial, the relevant global regulatory agency needs to be assured that the chemistry, manufacturing and control elements have been appropriately considered and documented.
Potential Mutagenic Impurity (GTI) Assessments
Arcinova have the expertise necessary to assess the mutagenic potential of impurities and degradation products required for successful regulatory submissions.
SMi Highly Potent Active Pharmaceutical IngredientsThe SMi Highly Potent Active Pharmaceutical Ingredients Conference will be attended by Mark Anstiss, Scale-up Chemist.
SMi Highly Potent Active Pharmaceutical IngredientsDates: 21st - 22nd MayLocation: Birmingham, UK
66th Annual ASMS ConferenceThe 66th ASMS Conference on Mass Spectrometry and Allied Topics Conference will be attended by Michael Blackburn, Method Development Scientist (Physiochemical). Michael will also be presenting during the conference, at the Proteins & Peptides Waters Users Meeting, with a presentation entitled; A Powerful Hybrid IA-LC-MS/MS Method Quantification of Insulin Analogues and
66th Annual ASMS ConferenceDates: 3rd - 7th JuneLocation: San Diego, US
2018 BIO International ConventionThe 2018 BIO International Convention will be attended by Mark Chadwick, Head of Business Development.
2018 BIO International ConventionDates: 4th - 7th JuneLocation: Boston, USA