NDA Partners Featured in Article on Growth of Pharma Disruptors

NDA Partners LLC, a consultancy of which I am a member, was featured in a news article in Business Worldwide.

The article notes that the pharmaceutical and medical device industry has the most complex regulations of any industry. They take at the unique consultancy services provided by NDA Partners.

The article notes: “…NDA Partners LLC, which provides product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide, has developed a new model of consultancy – the CDO or consulting and contract development organisation. And it’s a model that is entirely suited to small innovators and SMEs.”  “NDA Partners distinguishes itself from other consultancies through its ability to assign top-tier expert consultants on all engagements. It provides the full spectrum of functional expertise needed to conduct complete product development programs from bench to marketing authorization”

NDA Partners includes as consultants:

  • Three former US Food and Drug Administration (FDA) Centre Directors
  • Fourteen former FDA Director or Deputy Director Division heads
  • The former Head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Three former EU regulatory agency senior staff
  • The former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP)
  • Dozens of highly experienced former biopharma and medical device industry executives

 

European Medicines Agency approvals for 2016

in 2016, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing authorization.  Of these 27 were “new active substances” and 17 had an orphan designation.  There were 2 negative opinions, which later went on to receive a positive opinion. None of the approvals were for ophthalmic products.