Pharmaceuticals & Medical Devices

We provide a wide range of regulatory services supporting pharmaceutical products and medical devices.

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Regulatory Submissions

We provide support for a broad range of regulatory filings, such as:

NDAs
ANDAs
505(b)(2)s
INDs
510(k)s
De Novo
DMFs

Non-Clinical and Clinical Study Support

We assist with study planning and design, and provide oversight of CROs to ensure generation of high quality data and reports that are suitable for regulatory filings. We also support IRB submissions, regulatory writing, and ad hoc analytics.

Literature Reviews and Publication Support

Our team can prepare meta-analyses, systematic, comprehensive, and narrative reviews for regulatory filings or publication in peer-reviewed journals. We also provide publication strategy and management to get your science to the forefront.

Advanced Data Analytics

Our team supports post hoc analyses, clinical decisions algorithm development, reviews of nationally representative surveys, and much more. We provide data analytics and visualizations for any audience from regulators to the general public.

Advisory Committee Meetings

Our team offers full-service support for ad comm meeting preparations. This includes creation of briefing materials, presentations, and Q&A materials. We can also provide scientific experts to participate as responders during the meeting to supplement your internal team.

Drug Safety and Pharmacovigilance

We have extensive experience meeting FDA's post-market requirements for a wide range of products. We provide support for study design and execution, use of real-world evidence, and data analytics, and report writing to keep your product on the market.