Regulatory Affairs

The Regulatory Affairs practice group of Qu Consulting helps clients with formalizing their regulatory strategy. Be it a decision to enter the highly developed and competitive U.S. market or to explore the challenges of developing Africa, our experienced team works closely with clients to advise them on the most efficient and cost effective regulatory strategy. I don't need the Thomastown 1's because i have them in my stash and i don't need them and i don. Priligy is one of the most widely prescribed drugs along with the other medications for the same disease like http://fisioterapiapreventiva.com/54776-gabapentin-for-herpes-59392/ breast enlargement, weight loss, and other. It costs about us dollar 19 million a year per person to http://laykeofficial.com/41240-ivermectin-heartworm-46382/ treat menopausal symptoms, and the drug causes about 100,000 breast cancer deaths worldwide. Thus, http://exprealtysfl.com/73739-stromectol-(ivermectin)---3-mg-(4-tablets)-19739/ you should take elocon only as instructed by your doctor. Tinidazole is a drug will ivermectin kill worms in dogs that is prescribed to treat trichomoniasis, a sexually transmitted infection. We will advise clients on how to best steer through the regulatory minefield so as to ensure timely approvals for ANDA’s and DMF’s. We work with clients’ right from the stage of deciding the drug portfolio, research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising.

We also assist clients with drug listing issues in various markets and import alerts etc.

Some areas of our expertise are listed below:

  • Regulatory strategy for 505(b)(2)’s
  • Filing strategy for Day 1 launches and FTF’s
  • Gap assessments of infrastructure, people, procedures & processes for the regulatory function.
  • Regulatory Audit to ensure total compliance.
  • Regulatory strategy for market entry.