Regulatory strategy

Form a concept to bring your new products to the market

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Drug development

Drug discovery, pre-clinical and clinical testing

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Agency interactions

Get you product approved

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Regulatory procedures

Find the right procedure to register your product

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Submissions

Prepare your documents for submission

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CTD / eCTD

Structure your regulatory information as a Common Technical Document (CTD)

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Artwork & labelling

Create compliant artwork and labels

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Pharmacovigilance

Meet all safety regulations during the lifecycle of your products

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SOPs

Formulate procedures to assure control of production and processes

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Technical writing

Create module 3 (Chemistry Manufacturing & Controls) of your dossier

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Regulatory intelligence

Research, analyse, screen and always be up-to-date with regulatory information

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Post-approval & life cycle management

Manage the entire lifecycle of your product - conception, design & manufacture, distribution and disposal

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Due diligence

Review your regulatory information

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Software selection & validation

Find the best suitable software for your Product Life Cycle Management (PLM)

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SOP templates
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