Streamlining Your Drug Development Journey with Our Regulatory Affairs Expertise
Our regulatory affairs team anchors our integrated drug development solutions model, offering expertise as you navigate each phase. We offer a complete Regulatory Solution by delivering expert end-to-end Regulatory Affairs and Regulatory Operations services for biotechnology and pharmaceutical companies from early product development to commercialization.
Our Regulatory Affairs Solution
Our dedicated Regulatory Affairs and Operations experts offer responsive support, guiding clients through the complex challenges in an evolving product development and commercialization environment. With deep technical knowledge and global industry experience, we deliver practical regulatory strategies, setting clients up to navigate challenges.
We determine the most efficient regulatory path for your compound and guide progression through each development phase. Whether supplementing your internal team or serving as your dedicated regulatory affairs resource, we build a strategy that supports your project’s success from the start.
Life Cycle Management
Our team provides global regulatory guidance and advice, leadership and informed insight to set and implement successful regulatory strategies to all stages of drug development including gap assessments of existing drug development programs, regulatory roadmaps, strategies for special designations and accelerated pathway approaches, coaching and preparation for communication and interactions with Health Authorities.
- Regulatory Drug Development Plans: We offer comprehensive global or regional regulatory development plans that lead your product from concept to commercialization, enhance investor relations, and streamline organizational objectives.
- Customized Regulatory Support: We provide regulatory support tailored to your program's needs.
Drug Discovery and Nonclinical Phase
- Nonclinical Regulatory Development Plans: We minimize risk by assessing gaps and providing strategic oversight, ensuring your nonclinical program aligns with regulatory requirements, anticipating challenges, and keeping your project on track.
- Regulatory Pathway Review: We evaluate and confirm your drug development plans, identifying expedited regulatory pathways to enhance your strategy.
- IND/CTA-Enabling Packages: Our team facilitates the rolling authoring of your IND or CTA and Investigator’s Brochure, ensuring pre-IND or pre-CTA materials reflect emerging data and current issues for effective agency interactions.
- Formulation and CMC Advisory: We provide regulatory oversight of your formulation development, to resolve CMC challenges and prevent delays.
Phase I/II Development
- Pre-IND/Pre-CTA Meetings: From developing agency interaction strategies to leading pre-meeting preparations and fulfilling post-meeting requirements, we ensure your questions are addressed and risks minimized.
- IND/CTA Filings (and Post-Approval Maintenance): Our experts assess gaps to ensure requirements are met while authoring IND or CTA modules to the highest quality standards. After submission, we prepare thorough responses to review queries to streamline approval processes. Once approved, we maintain your IND or CTA, filing amendments and notifications, and preparing annual reports.
For additional information on our small and large molecule integrated solution, consult the following webpages: