Expert Regulatory Strategies for Drug Development
Accelerate pharmaceutical approvals with tailored consulting services.
Expert Regulatory Strategies for Drug Development
Accelerate pharmaceutical approvals with tailored consulting services.
About Hill Regulatory Consulting
Our Mission
At Hill Regulatory Consulting, our mission is to help human and animal health businesses thrive. We do this by providing comprehensive regulatory consulting services that are tailored to the unique needs of each client. Our team consists of Subject Matter Experts with decades of experience developing and executing regulatory strategies for streamlined approvals.
Welcome
Welcome to Hill Regulatory Consulting, your trusted partner for all your regulatory consulting needs. As part of your in-house team or as your "off-site" partner, our Subject Matter Experts offer tailored solutions to help you achieve your goals and maximize your success.
Consulting Services
Regulatory and Development Strategy
Our team of experienced consultants will work with you to create a solid regulatory and development strategy that aligns with your business goals and objectives. We'll help you identify gaps in scientific data (CMC, non-clinical, clinical), opportunities for expedited approval and create a plan to achieve success.
Regulatory Submission Services
Submission services are provided for animal and human pharmaceuticals of all types and dosage forms (small and large molecules,generic and prescription), devices and combination products in a wide range of therapeutic areas (IND, NDA, BLA, INAD, NADA, DMF, etc.). Services are also provided for all types of FDA meetings through Post Approval Supplements.
R&D Project Management
Research and development and project management services are provided to facilitate execution of regulatory and development strategies, or technical transfer activities for manufacturing of drug substance or drug product, analytical testing, or other chemistry, manufacturing, and controls (CMC) - related changes to facilitate filing initial regulatory submissions or post approval supplements.
Due Diligence
Perform due diligence activities for product acquisition or portfolio assessment.
Other FDA- Related Services
Act as US Agent, review of scientific or regulatory documents, corporate or individual training activities
Contact Us
Hill Regulatory Consulting
5213 Parkwood School Rd, Waxhaw, NC 28173
