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Create The Correct Checklist To Land The Best CDMO

When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static.

Stephanie gauldingPharmatech associatesMaster service and quality agreements workCultural fit and build

Should I Request A Q-Submission For My Medical Device

Q-Submissions are a mechanism is available to request feedback from the FDA. It is the pathway for a medical device sponsor to reach out to request a.

Caitlin bancroftPharmatech associatesRadiological healthDrug administrationDevice submissionsRequest for feedback andPremarket notificationPremarket approvalInvestigational device exemptionsSubmission issue requestsStudy risk determinationsIncrease the valueQ submission worthMedical device submissionsBiologics evaluationLeast burdensome provisions

What Should You Do To Prepare For EU (5362014)

In May 2022, Clinical Leader hosted a webinar on the EU (536/2014) regulation and the impact it could have on drug developers hoping to conduct.

Sylvia mareckiEd misetaMarieke meulemansThomas hagemeijerAdam lambertPharmatech associatesEuropean unionChief editorClinical leaderEuropean economic areaEastern europe

3 Strategies For Optimal Oversight Of Your Outsourcing Partner

Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This.

Stephanie gauldingPharmatech associates

New ICH Q14 Guidance Applies QbD To Analytical Procedures

ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life.

Analytical target profile developmentInternational council for harmonizationPharmatech associatesAnalytical procedure developmentAnalytical developmentBrian glassInternational council

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