SPECIALISTS IN GLOBAL REGULATORY AFFAIRS
PhaRA’s approach is REGULATORYproof
PhaRA is REGULATORYwise
Did you think that managing regulatory affairs was just a small project on the side?
Are you hesitating to leave your regulatory work in hands of external staff, and have you been waiting for a strategic and confidential partnership where forces are joined and talents are shared?
Are you merely seeking immediate support, or would you also prefer leaving regulatory affairs to experts who have focused their entire careers on regulatory affairs?
PhaRA is a consultancy firm in global regulatory affairs. By concentrating exclusively on regulatory affairs, we can offer in-depth knowledge, insight, skills, and experience. We are able to provide the services of a fully-staffed regulatory affairs department or complement existing resources at headquarters or BENELUX affiliates.
We have a highly qualified and motivated team of experts in place, who provide a personal and flexible service.
WE LOVE, LIVE AND BREATHE REGULATORY AFFAIRS
REGULATORY CONSULTANCY SOLUTIONS
Comprehensive regulatory affairs consultancy solutions for pharma and biotech companies
talent sharing
Temporary regulatory affairs staffing for pharma and biotech companies
SENIOR ADVISORY SERVICES
Senior advisory board of key RA opinion leaders
INTELLIGENCE and TRAINING
Tailored regulatory affairs intelligence services, training, workshops, and helpdesk support for various regulatory needs
MEDICAL WRITING
Writing expertise and support
We specialize in diverse therapeutic areas, from critical illnesses to OTC products. Our experts cover all types of products, from chemical and biological entities (eg, mAb, vaccines, ATMPs), to ADCs, devices and combination products.
Our end2end services start from setting global strategy to writing regulatory, CMC and medical documents, managing global labeling and executing regulatory procedures in EU and with WHO. Our expertise spans the entire product lifecycle, from early development to marketing authorization and lifecycle management.