Developing a product is only part of the task. Pre- and post-market support, health economics and product launch strategies are just as important. Our enterprising approach means that we will help you formulate a regulatory strategy that works to your advantage. And we don't stop with your product. Our teams are ready and waiting to support you as part of lifecycle management. Our teams are ready and waiting to support you through strategic regulatory consulting as part of our lifecycle management.
We ask the tough questions:
- What are the right trials to conduct?
- Is a certain activity really needed?
- Is this the best approach for your product?
Our global experience provides us with the necessary local expertise to help you plan for market success. We understand the regional requirements related to your product launch and can support you in assessing additional potential revenue streams from marketing approval or via out-licensing.
Custom solutions we provide include:
- Strategic regulatory consulting for product development and regulatory strategy for new therapeutics and combination products, including assessment of applicability of unique programs and pathways available for approval (e.g. breakthrough therapeutics, orphan drug status, eligibility for 505(b)(2)).
- Patent extensions and market protection
- Concept to commercialization strategies
- In-license and out-license support
- Review and/or preparation of Investigational New Drug (IND), New Drug Application (NDA), Biological License Application (BLA), Abbreviated New Drug Applications (ANDA) and lifecycle management submissions, such as Post Approval Supplements (PAS), all with eCTD format
- Assistance in clinical protocol design and clinical trial support (e.g. CRO selection and contracting, IRB selection, drug management/labelling) and advisory committee preparation
- Assistance with regulatory agency meeting interactions, including preparing briefing documents, organizing meeting preparation sessions and leading FDA meetings. These include pre-IND, end-of-phase-2 (EOP2), pre-BLA, Type A, Type C and advisory committee meetings
- Market analysis and forecasting
- Competitive intelligence
- Marketing survey development
Praise from our customers
Using Cmed's expert consulting team meant we were able to reduce our internal staff costs while having full access to true experts in order to accomplish our ambitious goals.
Medical & Scientific
In addition to support for your full service programs, our staff offers drug development experience and expertise to create bespoke programs and provide consulting services at any phase.
- Design input into clinical development plans, including early studies incorporating translational biomarkers for proof of concept – and later studies incorporating health outcome measures.
- Medical input into clinical study protocols, especially in complex or unusual indications.
- Advice on medical acceptable endpoints for clinical studies.
- Medical representation at key meetings such as KOL, agency or due diligence.
Maximize your ROI by ensuring the optimum pathway to market. Cmed’s consultants have extensive experience with medical device companies from small, emerging firms to the largest global organizations. The Cmed team’s expertise in various medical technologies includes projects from Class I to Advanced Therapy products and helps from conception, development and through licensing/commercialization in Europe, the US and Asia Pacific.
Get the most value from your device assets with Cmedâ€™s integrated commercialization, innovation and development strategy. We are prepared to help with:
- Innovation: Creating the environment for innovation to flourish in the face of increased competition.
- Development: Fine-tuning product and process development, marketing and regulatory capabilities.
- Commercialization: Accelerating the time to market for innovative new products.
- Value maximizing: Increasing the market value of existing and new products.
Our proven services
|Regulatory Consultation||Product classification; regulatory strategy; unique and combination products; due diligence; and emerging regulatory issues.|
|Regulatory submissions||IDE, 510(k), PMA, 513(g), European CE marking in Class III medical devices, and post-marketing submission support (PMA supplements, 510(k)s for device changes, annual reports, and post-market studies).|
|FDA and European agency interactions||Pre-510(k) and pre-IDE meetings; Competent Authority scientific briefings; advisory panel preparation and support; dispute resolution; and administrative appeal.|
|Clinical study design and evaluation||Patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts/publication development.|
|Global regulatory filings||All required filings|