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Local regulatory knowledge and up-to-date regulatory intelligence is vital when compiling dossiers and completing application forms for submission to Regulatory Authorities.
3D Clinical offers a comprehensive regulatory affairs service which encompasses the following: |
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Design Develop Deliver |
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3D Clinical Research |
Regulatory Affairs |
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So what exactly is 3D Clinical offering you? We offer the chance to get it right the first time thus saving you time and money. We offer you quality, compliance and regulatory acceptance. We offer peace of mind. |
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Regulatory submissions to Regulatory Authorities in Europe and the US (CTA/IND/NDA/MAA etc) |
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Dossier preparation and maintenance for MAAs/NDAs and Clinical Trials |
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Variations for MAA Product Licenses |
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SmPc / package insert updates |
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Clinical document preparation and maintenance |
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Clinical protocols or clinical investigation plans |
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Clinical protocols or clinical investigation plans amendments |
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Investigator Brochure and updates |
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Compliance checks for essential clinical trial documentation |
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Clinical protocols / clinical investigation plans |
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Patient Information Sheets and Informed Consent Forms |
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Case Report Forms or other data collection forms |
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Investigator Brochure |
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Regulatory advice |
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Best route to market |
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Regulatory requirements |
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Clinical development plans |
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Regulatory strategy |
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Literature searches |