by Nick | Mar 16, 2021 | Regulatory Affairs
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...
by Kamile Gruduls | Mar 15, 2021 | Regulatory Affairs, Webinar
Webinar: Medical Device Registration in Russia. Challenges and Issues The purpose of this webinar is to show the differences and specifics of regulations and law processes that can cause challenges in medical device registration in Russia. You will learn about:...
by Kamile Gruduls | Mar 13, 2021 | Regulatory Affairs, Webinar
Webinar: eCTD Submission Different 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...
by Nick | Mar 11, 2021 | Regulatory Affairs
An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring...
by Nick | Mar 11, 2021 | Regulatory Affairs
As the electronic Common Technical Document (eCTD) became the standard for submitting Regulatory Information to leading agencies worldwide, its adoption still poses a considerable challenge for those agencies who lack the needed human and/or material resources. How is...
by Nick | Oct 21, 2020 | Pharmacovigilance, Regulatory Affairs
Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information...
