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PHARMAACTD DOSSIERS PK

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What is Regulatory Intelligence (RI)?

If we will search for RI anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy and legislation. Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities: • Gather Data: RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material. • Analyse Information: This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearranged having relevant information required according to lat…
Certificates of Analysis (CoA)


World’s future of business is in outsourcing and globalisation EU GMP Guide Part I (Chapter 4 and Chapter 6) - these chapters contains detailed information about safety and quality, Laboratory documentation should follow the principles given in Chapter 4.EU GMP Guide Part II - Section 11.4 –§Authentic Certificates of Analysis should be issued for each batch of intermediate or API on request. §Information on the name of the intermediate or API including where appropriate its grade, the batch number, and the date of release should be provided on the Certificate of Analysis. For intermediates or APIs with an expiry date, the expiry date should be provided on the label and Certificate of Analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or Certificate of Analysis. §The Certificate should list each test performed in accordance with compendial or customer requirements, including the accep…