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Regulatory Affairs

Services
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  • Preparation of CTD for Marketing Authorisation application
     

  • Ongoing contact with regulatory authorities on behalf of MA holder
     

  • Regulatory audits
     

Background

 

  • This is a new area of business led by CommQP's Regulatory Affairs Consultant
     

  • CommQP have contributed in assisting numerous clients attain MIA & WDAs.  These activities have ranged from API audits and provision of QP declarations to preparing sites for regulatory body inspections.
     

  • Previously in Mukesh's career, as Regulatory Affairs at Mars Inc., he attained MIA for the site and MAs for a novel dosage form in veterinary medicinal products.  These were the first truly palatable veterinary medicinal product to be approved by VMD in the UK.    
     

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