Tag: Synchrogenix
Synchrogenix Guides Company to Transparency and Disclosure Success
Plan to Accelerate Your Time to Drug Submissions
There are common themes driving how quickly you can get from your last database lock (DBL) to submission of your marketing application. Speaking from first-hand experience across more than 50 marketing submissions, Synchrogenix regulatory science experts will demonstrate how, through thorough planning, you can improve and shorten your speed to drug submission. Speakers Anjana Bose, … Continued
治験総括報告書のためのレギュラトリーライティングの専門知識
Scientists work toward an elusive dream: a simple pill to treat Covid-19
By Damian Garde The world has vaccines that can prevent most cases of Covid-19. It even has drugs that can help with the most serious symptoms of the disease. Now what it needs is a Tamiflu for SARS-CoV-2. It would be a pill, exquisitely (…)
Emerging Biotech Selects Synchrogenix, a Certara Company as Transparency & Disclosure Provider
Combining APIs: MPT Development & Regulatory Considerations
This third webinar in the “Let’s Talk MPTs” discussion series will provide MPT product developers and other stakeholders an overview of clinical development and regulatory considerations when developing products that combine one or more active ingredients into an MPT product. Speakers Dr. Virna Schuck, PhD is Senior Director of Clinical Pharmacology at Certara and has over 16 years … Continued
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
Starting June 24th, 2021, the US FDA will require all your post-marketing submissions of promotional materials and submissions of promotional materials for accelerated approval products be submitted via electronic Common Technical Document (eCTD) format. The 37-page guidance by the FDA titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials … Continued
Health Canada Regulatory Modernization: Yesterday, Today, And Tomorrow
Purity is a Virtue: 不純物報告に関する実践ガイド
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take away messages. We will start by defining the various … Continued
