PhaRA is a consultancy firm in EU and BENELUX 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 department or complement existing resources at Headquarters or BENELUX affiliates. All PhaRA consultants are pharmacists and/or PhD's with strong regulatory technical expertise. We love, live and breathe regulatory affairs.
Hopland 47/B7
2000 Antwerpen, Belgium
Tel. +32 3 293 90 84
Info@phara-consulting.be
Our team can advise and assist at all stages of the product lifecycle, starting from early phase development to the post-authorisation maintenance phase. Our expertise covers various therapeutic areas, and ranges from life-threatening diseases to OTC and borderline products. We have experience with all types of marketing authorization applications and procedures (CP, DCP, MRP, NP, Referrals), requests for scientific advice, Pediatric Investigation Plans (PIP), Orphan Drug Designations (ODD), Clinical Trial Applications (CTAs), labelling development and translation.