Regulatory Strategy Consulting
Our experts provide strategies for early and late drug life cycle management, ensuring our customers’ products are competitive. CMIC Group has experts who can develop regulatory strategies, from molecule strategy (early life cycle) to commercial strategy. In the development phase, we can plan for submission or early submission, and consider drug formulations that may prolong the period of exclusivity. During the commercial phase, we can assist with pricing strategies, introduction of new indications, post-approval changes for drug improvements.
Our Edge in Product Life Cycle Management
Drug development to meet Japanese market needs
- Our team understands the needs of the Japanese market, and we develop drugs that meet these special needs: tablet strength, taste, and other specifications.
- We have multiple particle coating and masking techniques for Orally Disintegrating Tablets (ODT) and pediatric drugs.
- Product Life Cycle Management consulting
- Addition of dosage forms
- Introduction of new indication