PHARA
Our Services
• Regulatory strategy and hands-on support throughout drug development, MAA filing and product life cycle for chemical entities, biologics and combination products
• Health authority interactions and Agency meetings with EMA and national competent authorities
• Regulatory scientific (CMC and medical) writing
• Regulatory due diligence and gap analysis
• Act as Head of RA or ‘virtual’ RA department for SMEs
• Strategic Advisory Board of key RA opinion leaders
Our Expertise
• Early & late phase development, eg, landscape analysis, road map, first‐in‐man CTA and preIND enabling, scientific advice, PRIME, ILAP, pediatric plans, orphan drug application, ATMP classification & certification, etc.
• Regulatory CMC, including project management and post-market change control
• Strategic planning and support for global CTA & MAA
• EU regulatory procedures, eCTD preparation, MAA filing
• Life cycle management and divestiture
• Global label development & remediation
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