Regulatory

Pharmaceutical companies (small molecules, biotech or vaccines) are facing challenges in bringing innovative products to patients. With an increased focus on safety and transparency by drug regulatory agencies, the ability to effectively interact with these agencies is crucial for success.

Eagle Rock Life Sciences will advise on the most efficient options and the smart choices for a successful outcome to both regulatory requirements and patients’ needs.
Specific services offered are:

• advice on product development, regulatory strategy and risk management
• guidance on options for regulatory pathways to get the product approved
• preparation for decisive oral hearings by scientific committees
• support on issue management with drug regulatory agencies
• advice on strategies how to switch prescription drugs to OTC (over the counter)