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Kinapse provides expert standalone document quality control services

2020-08-03T08:37:36+00:00

Back to Kinapse blog Kinapse provides expert standalone document quality control services The number of clinical trials as well as the amount of regulatory documentation required for each trial is increasing. The production of high quality documents within strict timelines is therefore resource intensive and demanding. By [...]

Kinapse provides expert standalone document quality control services2020-08-03T08:37:36+00:00

Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines

2020-08-01T11:19:07+00:00

Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines In 2018, the European medicines regulatory network became aware of the presence of N-nitrosamines in sartan APIs and instituted a series of regulatory actions across the EU, including recalls of some medicines [...]

Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines2020-08-01T11:19:07+00:00

Overview of the new drug regulation registration (DRR) in China

2020-06-25T14:31:36+00:00

Overview of the new Drug Regulation Registration (DRR) in China On the 1st July 2020 the new Drug Regulation Registration (DRR) will be implemented in China. There are a number of significant changes within this new regulation covering new marketing applications, clinical [...]

Overview of the new drug regulation registration (DRR) in China2020-06-25T14:31:36+00:00

Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities

2020-02-14T14:22:30+00:00

Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities The deadline to respond to EMA Art. 5(3) Referral on NITROSAMINES is fast approaching. MAHs are obliged to submit the conclusions of risk evaluations for all of their medicinal products containing [...]

Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities2020-02-14T14:22:30+00:00

Kinapse launches Plain Language Summary Portal

2019-11-19T14:40:36+00:00

Kinapse launches Plain Language Summary Portal Kinapse, a Syneos Health Company, a market leader in clinical trial disclosure services, announced the launch of ClinTrialDataShare.com, a web portal for sponsors to publicly share plain language summaries (layperson summaries, lay summaries, or results summaries) of clinical trials. With the aim to improve transparency of clinical [...]

Kinapse launches Plain Language Summary Portal2019-11-19T14:40:36+00:00