Regulatory Affairs and Pharmacovigilance
The Regulatory Affairs and Pharmacovigilance processes are critical in the pharmaceutical industry. They serve as the foundation for providing product/drug safety data and documentation. Our specialists are certified in medication safety. This necessitates functional tasks such as safety trend analysis, the maintenance of adverse reaction data, the upkeep of global safety databases, and the conduct of safety training to analyze the drug/medical product.
- Regulatory Due Diligence : It entails doing a comprehensive review of an organization’s regulatory compliance status as well as the status of its suppliers, agents, and partners. It is the process of verifying, investigating, or auditing a possible transaction or investment opportunity in order to validate all essential facts and financial information.
- Regulatory Strategic Planning : Advice on how to match the regulatory efforts needed to bring a new or modified product to market with the business or marketing plan. Giving the team overarching direction by identifying the critical regulatory aspects. It includes critical milestones and dangers to possible success in attaining a given regulatory result decision points.
- Designing ECTD : Get assistance in building the eCTD (Electronic Common Technical Document) to standardize the regulatory review process for worldwide drug development. Complete this unified structure in accordance with the ICH principles. It is the industry standard for submitting applications, modifications, additions, and reports to the FDA’s CBER and CDER.
- Application Process Management : Get support and assistance in the Application Process and make it almost hassle-free and quick!
- Pricing Process Management : It is a critical process that integrates all views and information required to constantly make appropriate pricing decisions. Good pricing control capabilities result in effective financial risk and revenue management.
- Overcome regulatory issues and challenges : Get professional support to overcome all the issues and challenges from the industry expert and settle your business hassle-free.
- Pharmacovigilance Management : The management of the process is undertaken to promote safe medication usage and protect patients’ health. Activities performed during the authorization of the drug’s authorization for the identification of risk assessment, risk minimization, and prevention of the medical product. Activities might incorporate safety evaluation implemented into clinical trials and the monitoring and reporting of adverse situations.
- Labeling art work and translation service.
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Location
Iris Bay Tower, 17th Floor Office 32, Business Bay, Dubai.