Planning a Health Canada PRCI Compliant Submission Blog Post
How to set yourself up for a successful Health Canada PRCI submission
Part 2: Oligonucleotide therapeutic development: Pre-clinical and translational considerations Blog Post
In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth…
Plan to Accelerate Your Time to Drug Submissions Blog Post
最終データベースロック（DBL）から販売申請の提出までのスピードには、共通する要因があります。Speaking from first-hand experience across more than 50…
A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development Blog Post
小児用PBPKモデルは、医薬品開発プロセスにおいて幅広い応用可能性を有し、臨床試験の最適化や代替手段としてますます活用されています。However, the approach has yet to become fully…
Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development Blog Post
Do expensive bioequivalence studies stall your generic drug approval? Learn how you can streamline complex generic drug development with our white paper.
Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure Blog Post
The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type…
Document Quality and Management Page
サターラの規制関連文書の品質管理およびマネジメントサービスは、申請者が規制当局への提出において正確性、コンプライアンス、効率性を確保することを支援します。
Legislators: Bring all stakeholders to the table to lower drug costs Blog Post
BY ROMAN CASCIANO, OPINION CONTRIBUTOR — 03/29/21 05:30 PM EDT No one is happy with the price of drugs nor how we pay for them: not patients, not the lawmakers who…
Strategic Evidence & Value Communication Symposium Blog Post
Join us on 2021年4月21日 (水曜日), from12:00 PM – 2:00 PM EDT for Certara’s first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.
Purity is a Virtue: A Practical Guide to the Reporting of Impurities Blog Post
多くの製薬企業が、原薬（DS）および製剤（DP）の不純物の特性評価や、それらを規制当局への申請にどのように組み込むかに苦慮しています。This webinar is designed to increase the…
