Anneessensstraat 3-5 B9
PhaRA is a consultancy firm in BENELUX and EU Regulatory Affairs providing strategic and hands-on support to Pharma & Biotech companies.
By focusing exclusively on regulatory affairs, PhaRA can offer in-depth expertise and skills covering a broad range of RA activities for chemical entities and biologicals.
Our BENELUX services and expertise cover submission and maintenance at national level of MAA for Rx and OTC products, notifications for borderline products, compassionate use and medical need programs, support to RMA and DHCP letters. PhaRA is the selected provider of the Clarivate BELUX regulatory intelligence services.
Our EU services cover all activities during development and life cycle management, including:
- scientific advice, paediatric investigation plans (PIP), orphan drug applications
- regulatory scientific writing
- labeling development and remediation
- strategic advice in early and late phase drug development
- clinical trial and marketing authorization application (CTA/MAA) preparation and MAA filing
- running EU procedures (CP/DCP/MRP)
- liaising and meetings with EMA, FAMHP and other national competent authorities
- life cycle management
- regulatory due diligence activities
- regulatory affairs intelligence services and training
Therapeutic areas of special interest include early phase development, infectious diseases, immune inflammatory diseases, (immuno)oncology, vaccines, and other unmet medical need areas.
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