Regulatory science at Fuglsang Pharma

Fuglsang Pharma is a consultancy company specialising in clinical science, 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.

Fuglsang Pharma offers calculation of sample size for FDA's PBE approach for inhaled products. Click here to download a bootstrap demo report.

Click here to read the publication introducing the bootstrap for FDA's PBE approach.

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). The company is registered in Denmark since 2012. Clients include generic 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.