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Pharmaceutical Manufacturing and Packing Sourcer
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Managing regulatory compliance has always been a challenge for organisations, particularly those in the pharmaceutical space. Stakes are even higher today as companies must balance adherence to strict, often exhaustive, and continuously changing policies and procedures with the desire to embrace digital transformation and accelerate business to keep up with growing global competition.
This leaves the regulatory affairs, as well as quality and compliance personnel, in the middle, serving as the conduit between standards bodies or agencies, and senior leadership representing manufacturing, supply chain, and other key operational functions. The back-and-forth can be dizzying as one side expects compliance at all costs and the other desires getting product to customers faster and more efficiently than ever.
Labelling is one such area that crosses departmental boundaries. For manufacturing and supply chain, the barcode label is the passport that enables the fast identification, transport, tracking, and delivery of product from production line to endcustomer. For the regulatory manager, that same label must conform to a myriad of regulations and standards, many of which are a moving target due to constant change.
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News and Press Releases |
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MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita
MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
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White Papers |
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New Temperature Profiles from a Global Study
Laminar Medica
Recently there has been an influx of temperature
mapping studies to collect sufficient ambient data to develop temperature
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specific shipping routes are required to ensure streamlined packaging and robust
lane qualification.
The most reliable method to develop
temperature profiles is to capture the actual reading from shipments, as well
as using the historical and meteorological data to increase the confidence
level.
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Industry Events |
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SAPHEX 2019
23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA
SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention
Centre, Johannesburg, South Africa.
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