Our Expertise
PHA FARMED provides integrated regulatory, quality, scientific and business-development expertise across the pharmaceutical and healthcare product lifecycle.
From development and regulatory strategy to quality, commercialization and European market entry, we provide flexible senior-level support tailored to the specific needs of each project.
EU & UK Regulatory Affairs
Regulatory strategy and support throughout the product lifecycle, from pathway assessment and submissions to authority interactions and lifecycle management.
CMC & Regulatory Documentation
CMC strategy and regulatory documentation from development through commercialization, including dossier support, gap assessment and technology transfer.
Quality & Compliance
Practical quality and compliance support, including QMS, GMP/GDP, supplier qualification, Quality Agreements and audit and inspection readiness.
Clinical Development Support
Regulatory and scientific support for clinical development, including regulatory strategy, documentation, medical writing and coordination with specialist partners.
EU & UK Market Entry
Helping international companies assess product readiness, define the regulatory pathway and build a practical strategy for successful European market entry.
Partnering & Business Development
Supporting licensing, technology transfer and international business development through identification and evaluation of suitable strategic partners.
ENTERING THE EUROPEAN MARKET?
Start with an EU & UK Market Entry Readiness Assessment
Expanding a pharmaceutical, biotechnology, medical device or healthcare product into Europe requires more than a regulatory submission.
PHA FARMED helps international companies evaluate their product, documentation and development status against EU and UK requirements and identify the steps needed for successful market entry.
ASSESS → IDENTIFY GAPS → DEFINE THE ROADMAP → ENTER THE MARKET