Are you Brexit Ready?
Konstantina Konstantinopoulou2020-09-30T08:44:44+00:00Back 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
Konstantina Konstantinopoulou2020-09-14T15:03:49+00:00US 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 [...]
The Value of Patient Voices in Plain Language Summaries Webinar
Konstantina Konstantinopoulou2020-09-10T10:44:33+00:00Plain 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 Products
Konstantina Konstantinopoulou2020-09-09T12:21:02+00:00FDA 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 [...]
