Registration Applications

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Do you need assistance with all you regulatory documentation needs such as preparation of Investigational Medicinal Product Dossiers (IMPDs) or clinical trial applications (CTAs),marketing authorisation applications (MAAs), variations, paediatric Implementation plans (PIPs), scientific advice briefing dossiers etc? CAMPHARM has many years experience and good relationship with the regulatory agencies in the EU.

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International Regulatory Intelligence

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Want to know what is happening with similar products in other markets from a regulatory viewpoint? Perhaps you need an in depth analysis of the market for your product? Wish to meet with the regulatory agency? Need general regulatory intelligence in the EU or another Country.

Do you want international regulatory intelligence on similar products in a Country?

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Regulatory Procedures

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Management of Regulatory Procedures

CAMPHARM can assist in helping you to manage your regulatory procedures in the EU and certain other countries. From planning your strategy on which procedure to use to meeting the EMEA or other regulatory agencies in the EU to project managing day to day activities leading to approval and beyond.

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Regulatory Strategy

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Strategic Project Planning for product development

Maybe you are in early stages of planning and you want some independent strategic regulatory on your product development plan? Maybe you want to get into new territories such as the EU were you have no or limited experience? CAMPHARM has many years of experience on working on traditional or innovative development plans with companies in the EU and perhaps we can help.
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