Advice on Regulatory Issues

3R PHARMA CONSULTING helps customers reach their goals in all phases of pharmaceutical development pre-approval and maintenance of marketed products post-approval.

The company’s extensive experience and knowledge in regulatory sciences, chemistry, and manufacturing and control (CMC) can be used to effectively reduce the risk of failure or delay.

Professional risk assessment plays a significant role in reducing the time from identification of a lead compound to submission, as well as the regulatory approval of a pharmaceutical product of high-quality and well-defined performance.

To achieve registration success, the execution of the correct strategy for filing in each region/country is vital.

3R PHARMA CONSULTING offers:

• Consulting on national or European scientific advice
• Support with arranging scientific advice meetings with national agencies
• Consultation on an appropriate regulatory strategy for filings
• Review and assessment of regulatory documents (gap analysis)