Regulatory services
Registrations:
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MAA
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Dosier Preparation
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eCTD Publishing
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Procedure Management
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National Procedure
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Decentralised Procedure
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Centralised procedure
Post Approval:
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Variations / Renewals
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MA transfer
Our services are equipped to handle unique regulation challenges in the pharmaceutical industry, from New Product Support to Life Cycle Management. We manage regulatory needs throughout the pharmaceutical industry.
We work with clients on the strategic planning of regulatory submissions with US and European Authorities.
We track regulatory changes around the globe and provides updates applicable to MAHs products. We do it weekly, monthly and 6 monthly updates. We also reconcile our updates with the MAH.
We can prepare and submit updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labelling based on the product post-authorisation use.
We help MAHs in responding to RA queries. Particularly related to product safety and PSUR assessment report.
We provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems
