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 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 [...]
