Pharmaceutical Regulatory Consulting
The intensity of bringing a new drug to market requires focus, diligence and concentration. This concentration is often broken when you’re faced with challenges related to:
Pharmaceutical Regulatory Affairs Consulting
Preparing your product for global commercialization is a daunting task. It requires extensive research, documentation, process development and focus. In order to satisfy your market authorization requirements, we ensure your documentation is complete and stand by your side during your auditor review.
We keep you on track with Pharmaceutical Regulatory Affairs Consulting, including:
- Regulatory Gap Analyses
- Quality and Product Certifications
- Regulatory Compliance Initiatives
- Auditing Services
Internal and External Pharmaceutical Audits
Internal and external audits are integral to your compliance strategy. External pharmaceutical audits ensure compliance with your vendor management program. Conducting regular internal audits maintains your obligation toward CAPA, continuous improvement and serves as a control to ensure compliance.
We partner with pharmaceutical companies to conduct internal and external audits and prepare remediation plans to guide you toward compliance or a satisfactory relationship with your vendors. We also work with you after an audit is performed to help monitor regulatory goals.
When conducting your pharmaceutical audits, we assess against agreed upon standards and regulations your:
- Written SOPs and processes
- Job descriptions and competence
- Documentation and validation
- Processes and records
- Facility management
- Quality control systems
Pharmaceutical Risk Management
Every product and process has risk associated with it. Pharmaceutical companies should have a methodology for identifying potential risks they may encounter to ensure their viability. You pharmaceutical risk management program should include identification of the risks, evaluation of their potential severity and detectability, and a process for mitigating risks.
One of the most important elements of a Risk Management Plan is determining whether or not the risks are preventable. This involves an investigation into the cause of each risk and identification of the probability of it occurring.
MethodSense helps pharmaceutical companies meet FDA risk management requirements by:
- Developing, implementing and assessing your Risk Management Plan
- Developing and assessing risk management tools
- Preparing documents and offering advice on regulatory submissions
MethodSense helps you rise to these challenges with our objective vantage point, bringing you clarity and direction.