KASA System FDA’s regulatory assessment has evolved from a summary-based review to a question and risk-based review with an integrated quality assessment. Over the years, the FDA has focused on the challenges of efficiency, consistency, and objectivity in its oversight of pharmaceutical quality. To [...]
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So far Konstantina Konstantinopoulou has created 17 blog entries.
Back to Kinapse blog Are you Brexit Ready? Do you know you only have 12 months to produce an eCTD baseline for your CAPs that have converted to UK MA’s? [...]
US Agent & Official Correspondent (OC) Services Download Kinapse US Agent flyer and learn more about our offerings. Download flyer Want to learn more? For more information on our US agent [...]
Plain language summaries (PLSs) aim to meet a need in the industry for clinical trial transparency in a way that is meaningful and understandable for patients and the general public. As the pharmaceutical industry steps up to meet this requirement, patient panels play a crucial role in ensuring that information shared by sponsors [...]
FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug ProductsKonstantina Konstantinopoulou2020-09-09T12:21:02+00:00
FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Summary: The USFDA recently finalized the guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products”. This guidance addresses repackaging of prescription and [...]
US Agent & Official Correspondent (OC) Services Are you planning to register and market your pharmaceutical, medical device or food and dietary supplement in the US? Do you have a US agent? All non-U.S. Food, Beverage, Dietary Supplement, Medical Device or Drug companies who [...]
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 [...]
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 [...]
Conferences and Workshop Presentations Creating Meaningful Phase 1 PK Lay Summaries Speaker: Vidhi Vashisht CBI Lay Summary Summit, Sep 2018 General Data Protection Rule: What is in for Redaction and Anonymization Speakers: Pooja Phogat and Shalini Dwivedi DIA Medical Writing India Chapter, Aug 2018 CBI Clinical [...]
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 [...]