Development & Regulatory Consulting
Facilitating successful compliance throughout your product’s entire lifecycle
We offer comprehensive regulatory, clinical, and product development consulting services to help minimize your product's development time and maximize its time on the market. With global strategic expertise that extends from the U.S. to European, Asian, Canadian, and South American markets, our consultants provide the best solutions for both established and novel pharmaceutical dosage forms across a wide range of therapeutic areas.
- Strategic, global approach to regulatory planning and product development
- Global network of regulatory experts with local knowledge
- Experience with established and novel pharmaceutical dosage forms
- Expertise in a wide range of therapeutic categories
- Track record of success with regulatory approvals
- Continuity of service from the lab to market
Our global regulatory services meet a wide range of strategic situations:
- Worldwide scientific and regulatory strategies
- Project management
- Product lifecycle management
- Providing compliance management and leading product-development advice on intellectual property, quality issues, line extensions, and generic development
- Access to broad network of in-house specialized regulatory and development experts
- General scientific advice
- Non-clinical and clinical planning and project management
- Regulatory submissions at investigational and marketing stages
- Regulatory guidance
- CTD compilation
- Regulatory compliance and audit
- We provide manufacturing, testing, and packaging audits as well as complete compliance/validation programs.
- Technical and medical writing
- Regulatory due diligence
- Regulatory electronic publishing
- Catalent expertise encompasses paper and electronic regulatory submissions, study reports, and publications.
- Key services include:
- Training workshops
- We offer specialized trainings so you can benefit from our extensive pharmaceutical experience.