For companies engaged in clinical development programs for pharmaceutical products, robust regulatory support is essential for obtaining trial approval and initiation, as well as maintaining regulatory compliance throughout the process. At Asphalion, we provide comprehensive support for initiating Clinical Trials in the EU, with over 20 years of experience assisting companies in their clinical development:
- Customized Strategic Consultancy: We offer product-specific development strategies, including identifying CMC requirements, conducting gap analysis of non-clinical studies, and providing clinical study design consultancy.
- Scientific Advice Sessions: We coordinate meetings with National Competent Authorities for validation prior to starting clinical research.
- Regulatory Documentation: We manage the complete writing of all sections of the IMPD and IB for any type of product.
- CTA Submission and Preparation: We oversee the entire submission process of the CTA via CTIS.
- Regulatory Management Throughout Trial Lifecycle: We handle trial maintenance, including amendments and notifications, throughout the trial duration.
- Drug Safety Management: We take care of all required safety activities, such as SMPs, SAEs, SUSARs, and ASRs, as well as maintaining the safety database.
Upcoming Training: As experts in EU CTR and CTIS, Asphalion will be offering a training session on using the CTIS platform on September 17th at our Asphalion Knowledge Center.
We also provide similar services in the UK (IMPD and IB Writing, IRAS submission) and the US (IND Writing and Electronic Submission Gateway to FDA).
Explore our document to see the full range of services we offer. We look forward to discussing your clinical trial needs in Europe. Contact Asphalion at [email protected]
