REGULATORY AFFAIRS
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PCX Global ability to assess issues and provide strategic planning is effective and unique. In serving clients’ needs we add value to avoid high costs and irreversible mistakes.
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When starting product approval submission, PCX Global is focusing on achieving market access and commercialization in a timely manner. Our focus considers your need to maintain a long- term market presence. On compliance issues we help to avoid the often times serious consequences which can arise through actions imposed by the regulators.
REGULATORY AFFAIRS SERVICES
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Regulatory Strategy Development
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Product Development Process Optimisation
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Product Specific Regulatory Solutions
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Global Regulatory Document Preparation
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Regulatory Submissions and Publishing
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Medical Writing
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Product Labelling
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Regulatory Intelligence
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Regulatory Compliance
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Regulatory Affairs is an area of rapid change and ever-increasing demands. Companies in healthcare sector need to work smarter than ever before. Regulatory cooperation is a key strategy that assist Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies to focus on their core competencies and innovations.
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At. PCX Global, we understand the regulatory process and can guide your project to approval and market access. From general compliance issues, reporting requirements and product approval submissions, PCX Global has the experience to help manufacturers navigate the often-confusing regulations, policies, guidelines and practices in an ever-changing regulatory environment.