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.
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, prescription, and over-the-counter), devices,
and combination products in a wide range of therapeutic areas. Submission types include DMFs, INDs, INADs, NDAs, BLAs, ANDAs, NADAs, 510ks, PMAs through post approval supplements. FDA meeting services are also provided.
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 a US agent, review scientific or regulatory documents, and conduct corporate or individual training activities.
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