Early planning can help drug developers manage the technical, manufacturing and patient-use challenges of transitioning from a vial to a prefilled syringe.
Digital design is unlocking new levels of flexibility in complex dosage forms. See how additive manufacturing supports patient centric drug development and regulatory momentum. Read the full article.
Why cost, data readiness, company culture and trust continue to limit broader use of modeling and simulation across pharma development and manufacturing.
Covectra provides “bow-to-stern" serialization solutions for better ROI. Covectra’s AuthentiTrack® provides a comprehensive and modular approach to serialize down to the unit of use. AuthentiTrack® software has been awarded the EPCIS mark by the EPCGlobal Software Certification Program, a standards-based compliance testing program sponsored by the GS1 organization. ControlTrack® is a serialization-based solution to track down to the unit of use from the point of sale into the hands of the patient.
Sentry BioPharma Services ApS (Sentry EU) is a contract service organization (CSO) which supports the life science industry throughout the drug development life cycle by offering cGMP temperature-controlled storage, distribution, logistics, and EMA compliant labeling and packaging services. Sentry EU's Qualified Person (QP) facilitates import/export of pharmaceuticals to/from the EU via QP audits, QP-to-QP agreements, and batch certification/declarations. Sentry EU’s validated software, cGMP storage and drug distribution facility, industry expertise, and stringent quality standards support pharmaceutical supply chain integrity throughout manufacturing, packaging, storage and distribution.