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Some of the various Projects our consultants have worked on in the past.

REMS Consulting

Our Staff have had experience consulting on various REMS Projects, from the LA/ER Opioid REMS to the TIRF REMS. Having worked on such Risk Management programs as iPLEDGE, the LA/ER REMS, and other, our consultants understand the what the FDA is looking for with Risk Evaluation and Mitigation Strategies, and can guide you through the process.

Expedited Programs

Our Staff have provided guidance on Expedited Programs, including Fast Track, Breakthrough Designation, and Priority Review in the United States, and PRIME in the EU. Additionally, having worked with multiple Orphan Designation products, our Staff is knowledgeable in gaining Orphan approval in both US and EU.

Health Authority Meeting Preparation

Our Staff have in depth experience creating briefing books and helping companies prepare for Health Authority Meetings in the United States, European Union, United Kingdom, and Canada. We work closely with your team to ensure that all aspects of the meeting are understood, and that your team is fully prepared to meet with the Health Authorities.

Audit Preparation

Our Staff have wide ranging experience in auditing sites. We will help your team prepare for and be ready for audits when Health Authorities come to inspect. We can train your team to understand what the Health Authorities are looking for and how to be prepared for an Audit.

Legacy Conversions & Labeling Work


Many companies still have older labeling, and our Staff have worked on converting these old labels to the more modern standards, especially PLR. In addition, our staff is well versed in CCDS creation and the latest Labeling requirements to ensure your labeling needs are met.

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