Regulatory science at Fuglsang Pharma
Fuglsang Pharma provides consultancy services with emphasis on clinical science, GCP, data integrity, fraud detection & prevention, due diligence, regulatory strategies and quality audits for the pharmaceutical industry. The main focus is on CTD module 2 and 5 for medicines that are difficult to develop or difficult to get approved at EMA, FDA, TPD and TGA.
Formulation types handled by Fuglsang Pharma:
- Orally inhaled products
- Biologics / biosimilars (from simpler peptides to mABs)
- Eyedrop suspensions
- Transdermal patches
- SODFs, incl. modified release products.
Due diligence involves assessment of regulatory chance of success, gap identification and mitigation strategies.
Fuglsang Pharma was founded in 2010 by Anders Fuglsang, PhD, who is a former regulator (clinical assessor). Present and former clients include companies, innovator firms, the World Health Organization, the United States Pharmacopeial Convention and investment banks. Please click the 'contact' tab for details on how to get in touch. Fuglsang Pharma is not a lgeal entity. Anders Fuglsang operates as sole proprietor / freelancer.