GEA Pharmaceutical A/S has gained years of experience that we want to share with you. Involving Regulatory Affairs in a development project at its earliest stage guarantees the most efficient strategy and an optimal result at the end of your development process.
Regulatory Affairs is represented in the development teams to ensure competent and timely input on the latest regulatory requirements and authority practices.
Regulatory Affairs provides services within:
| • | Preparation and assessment of regulatory documentation
including Drug Master Files |
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| • | Application of Certificate of Suitability |
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| • | Adjustment of regulatory documentation from non-EU to EU
requirements or vice versa |
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| • | CTD conversion from former Notice to Applicants format |
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| • | Regulatory strategies |
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| • | Regulatory procedures - national procedures, Mutual Recognition
Procedures (MRPs), Decentralised Procedures (DCPs) |
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| • | Non-e-CTD electronic Submissions (NeeS) |
