At Akkeri, we specialize in providing scientific strategy and operational support to biotech and pharmaceutical companies navigating the complexities of nonclinical drug development. Whether you need full program support or a specific task, our services are adaptable to help you meet your goals efficiently and effectively.
We bring decades of experience and expertise in nonclinical drug development for all modalities, including extensive knowledge of regulatory pathways. Whether you’re advancing a novel therapy or optimizing an existing program, our team is here to support you at every stage.
Provide strategic and scientific advice by expert consultants
Develop nonclinical program plans to support clinical/CMC/regulatory strategy
Integrate innovative approaches (e.g. NAMs, weight of evidence) to reduce animal usage while maintaining a high level of safety assessment
Design, implementation, and oversight of nonclinical studies (pharmacology, ADME, toxicology)
Review/write nonclinical study reports to ensure accuracy, quality, and scientific rigor
Study monitoring and CRO qualification
Develop approaches to establish clinical starting dose and dose escalation based on toxicology and pharmacology data
Document preparation for regulatory submissions and meeting participation in support of global Regulatory Authority interactions
Author position papers, targeted data summaries, product labeling
Due diligence and gap analysis - participation in both in- or out-licensing partner discussions
At Akkeri, we understand that no two drug development programs are alike. That’s why we take the time to learn about your specific therapeutic goals and challenges, creating customized strategies that align with your unique needs. From study design to regulatory submission, we provide actionable insights and solutions that drive your program forward.