Regulatory Sciences
and Due Diligence

REGULATORY SCIENCES

  • Guidance on nonclinical and clinical regulatory strategy on all biopharmaceutical products
  • Expert advice on orphan drugs designation, break-through therapy, accelerated approval, ANDA and 505(b)(2) submissions
  • Conduct scientific and business centric due diligence assessments (on-site and/or electronic) of new drugs and acquisition

SERVICES