Who needs to review Batch Records?
The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a
Our highly experienced specialist offers full technical and commercial assessment over European markets identifying opportunities of business grow, utilizing the latest IMS data.
We will provide you a complex strategy plan for market entry, with the right form (private label), arranging tailored made/build dossiers.
We have developed the environment that could produce market analysis; evaluate the molecule potential, advise on preparation of due diligence & ventures activities from business development to product development and from out licensing to in licensing.
The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a
With the start of the application of the EU CTR on 31 January 2022, the MHRA (UK Medicines and Healthcare products Regulatory Agency) has launched a public consultation on proposals for legislative changes for
For companies with a valid establishment licence for the manufacture of medicinal products and transplant products, Swissmedic issues GMP Certificates on request. GMP Certificates from Swissmedic show the date of the inspection
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