Your One-Stop Regulatory Affairs Solution.
Providing tailor made solutions to suit your regulatory affair needs.
PharmaGlobus is your partner in getting Drug Product Licenses approved and Product Dossiers maintained in Europe. In doing so PharmaGlobus works seamlessly with you and your team by providing you cost effective, flexible and performance-oriented solutions to Drug Regulatory Affairs.
Our Services.
Tailored solutions for your pharmaceutical regulatory needs.
New Product Licence.
We facilitate and guide your new marketing authorization applications towards approval within EU countries with your choices for National (NP), European (MRP/ DCP) and Central (CP) application procedures. In doing so we work together with you to prepare pre-submission meetings with Health Authorities, evaluate relevant product dossier documents including those from your ingredients suppliers and compile the required CTD Modules 1-5.
Maintenance.
We offer ongoing maintenance services to ensure that your regulatory compliance stays up-to-date. Our team periodically compiles, reviews your regulatory documentation and implements any necessary changes to keep you fully compliant with relevant regulations such as submissions of variation and renewal application. We also accompany all during procedure raised questions, e.g. letter of deficiencies from Health Authorities. With our maintenance services, you can focus on your core business activities, knowing that your regulatory needs are taken care of.
Publishing.
We publish and submit your NeeS or e-CTD submissions to the authorities on a regular basis or ad hoc anytime.
Training.
Our customized training programs cover the latest regulatory requirements and best practices. Our expert team delivers engaging sessions tailored to your specific needs, equipping your team with the knowledge and skills needed to achieve and maintain regulatory compliance.
