Product development teams getting started on preclinical exploration of a potential treatment need a nonclinical expert on board as the primary authority on product safety – a requirement of regulatory authorities. The role of these experts is to ensure that safety issues are addressed consistently throughout the development lifecycle.
At Allucent, our experts serve this role and much more. We help design tailored nonclinical development programs that meet regulatory requirements in the most cost-effective and time-efficient manner without compromising the quality of the overall safety assessment. The scope of our services includes a product-specific nonclinical regulatory strategy, which is typically captured in a nonclinical development plan. This comprehensive document lays out the steps needed for a successful IND/CTA filing, along with the nonclinical program required to support clinical development beyond the initial clinical studies. Our experts can also conduct assessments of your development programs and nonclinical strategy to specifically identify gaps, and prepare a gap analysis report which encompasses concrete recommendations for taking action to correct deficiencies.
Regulatory support of your nonclinical program is key to our services. We anticipate assess, manage, and communicate potential risks to your development program, and help you navigate the complex regulatory landscape and respond to agency inquiries. With several former regulators on our staff, you can be confident in our knowledge and proficiency. Our team is highly experienced with the nonclinical safety development requirements of regulatory authorities in the U.S., Canada, the EU, UK, Australia, and Japan. We have worked across multiple product types including drugs, biologics, devices, and combinations. With extensive experience with the FDA centers CDER, CBER, and CDRH, we understand how the centers interact and collaborate when you have a combination product submission – an invaluable element of our support.
From Allucent, our clients have come to expect close collaboration, responsiveness, and clear communications, with the level of attention they need from our team to deliver on their commitments expeditiously. To ensure comprehensive insights, we work in partnership with our internal colleagues in Clinical Regulatory Strategy and CMC.
In addition, our nonclinical team has broad experience in planning, writing, and reviewing the nonclinical sections for pre-IND meeting packages and supporting FDA INTERACT meetings.
Regulatory submission support and Health Authority engagement
- Nonclinical meeting support including FDA, EMA, Health Canada, MHRA, and regulators in APAC regions
- IND, IMPD, and IDE submissions
- Clinical Trial Applications (CTAs)
- Scientific Advice, PR
- Protocol assessments, such as Special Protocol Assessment (SPA)
- End-of-phase meeting packages
- NDA, BLA, MAA and PMA submissions
Our toxicologists have extensive experience in planning, conducting, and monitoring toxicology studies using a broad variety of routes of administration, and in an array of animal models.
- ADME studies
- Safety pharmacology
- Single-and repeat-dose toxicology
- Reproductive and developmental toxicology
- Abuse liability
- Neurotoxicity studies
Our nonclinical team can provide the specific or unique support that is needed for your development program.
Nonclinical Program Support
- Generating product-specific study outlines for costing purposes
- Contacting qualified nonclinical testing facilities to request competitive price quotations, assisting with cost negotiations, and setting up details for the contractual agreement between the nonclinical testing facilities and the sponsor
- Estimating test article requirements
- Negotiating and implementing study schedules to streamline the nonclinical development program and achieve project milestones
- Reviewing and implementing study protocols to ensure that they fulfill project needs and regulatory requirements
- Acting as the main contact for technical and scientific toxicology issues raised during the conduct of the studies
- Reviewing draft reports and ensuring their finalization in a timely fashion for inclusion into the regulatory submission(s)
- Analytical and bioanalytical support for the nonclinical program, including costs and scheduling, method validation studies, and PK/TK analysis and modeling