The number and complexity of regulatory documents has increased significantly in the last decade as the volume of clinical trials and the regulatory burden have grown. The expedited clinical research for Covid -19 vaccines and therapeutics has further demonstrated the need for rapidly generating high quality regulatory documents to ensure patient safety [...]
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So far Konstantina Konstantinopoulou has created 20 blog entries.
Nitrosamine Impurities in Medicinal Products Back to Kinapse blog In 2018, the unexpected discovery of nitrosamine (probable human carcinogen) impurities in several angiotensin receptor blockers (ARBs) triggered a series of regulatory actions [...]
Kinapse welcomes you to ICH Q12 Back to Kinapse blog December 2020 Health Canada has recently released an update on the implementation of ICH Q12 in Canada . The target timeframe for implementation of ICH Q12 has been set [...]
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 [...]
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? Download flyer [...]
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 Konstantinopoulou2020-12-07T09:35:36+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 [...]