Regulatory Sciences
How to Create Successful Pricing and Reimbursement of your Pharmaceutical Product in the Nordics
Our Nordic region features world-class healthcare. Understanding the Nordic healthcare and market access landscape is crucial for successful pricing and reimbursement of your pharmaceutical product....
Medical Information
Enhancing Animal Health Compliance with Comprehensive Medical Information (MI) and Pharmacovigilance (PV) Services
Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and...
Regulatory Sciences
UK/EU Regulatory Developments Review 2023
Introduction The year 2023 has been remarkable in terms of regulatory developments within the UK and EU, characterised by substantial changes, innovative approvals, and strategic initiatives in the...
Clinical Research Solutions
Navigating Expedited Regulatory Pathways in Europe: The Latest Insights and Advancements
Are you truly up to speed on the most effective strategies to expedite the approval process for your innovative product in Europe's evolving regulatory landscape? In the United States (US), the Food...
Clinical Research Solutions
EMA Policy 0070: Back on the Road to Transparency
By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy...
Clinical Research Solutions
Integrity and Reliability Concerns in Bioequivalence Studies: An Insight into the Synapse Labs Inspection
In a globalized pharmaceutical industry, ensuring the integrity and reliability of clinical data is of utmost importance. Recently, the Spanish Medicines Agency conducted a comprehensive Good...
Clinical Research Solutions
EMA’s Regulatory Science Strategy to 2025 is on Track
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...
Clinical Research Solutions
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
Clinical Research Solutions
EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox
August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...
Clinical Research Solutions
EMA COVID-19 guidance: research and development
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...