CMC: Effective Writing Of IND And IMPD
Do we truly know how to ensure a well-written IND or IMPD Quality (CMC) part? Consistent and clear technical language? How to effectively manage the writing process? Biomapas can help you answer these questions and to set up the initial IND/IMPD required to start...
Webinar: Effective IMPD Writing. The Quality Part
Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is required by competent authorities in EU. The...
Expediting access through Reliance Pathways: MENA region
Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities. Recently, several National Competent Authorities (NCA) in the Middle East North Africa...
Webinar: eCTD Submission Strategies. In-house vs. Outsourcing
eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions and countries. That and diverse technical resources by companies often lead to various regulatory strategies. Thus, the questions arises: how to choose the...
