At BioMDg, we understand that evaluating a new product concept is crucial for its success in the competitive landscape of biologics and medical devices. Our tailored Scientific Business Plans cater to specific audiences, whether they are knowledgeable investors or clinical practitioners. By crafting comprehensive business plans that highlight the unique value propositions of your product, we ensure that your stakeholders clearly understand its potential. This not only aids in attracting investment but also facilitates informed discussions with scientists and clinicians in the field.
Navigating the regulatory landscape can be complex, but our expertise in regulatory strategy development ensures you take the optimal pathway for product approval across the US, Canada, and Europe. We meticulously assess your product’s requirements, providing you with a roadmap that includes critical steps for achieving compliance. Our team acts as a liaison with Notified Bodies and Competent Authorities, streamlining communication and facilitating strategic discussions with the FDA. This collaborative approach allows us to address potential hurdles early in the process, giving you the confidence to move forward. Interested in optimizing your regulatory strategy? Reach out to us for a consultation.
Valuation of New Technologies: Maximizing Potential
In addition to our strategic planning, we conduct thorough due diligence and valuation of new technologies to help you make informed decisions. By evaluating existing technical and clinical data, we identify strengths and areas for improvement, enabling you to position your product effectively in the market. Whether it’s determining pre-clinical and clinical requirements, submitting down-classification petitions, or applying for orphan designations, our team is dedicated to supporting your journey from concept to commercialization. Don’t leave your product’s success to chance—get in touch with us today to explore how our consulting services can propel your project forward.
Your Pathway from Concept to Commercialization
BioMDg offers the following services to successfully evaluate a new product concept:
- Scientific Business Plans – Tailored to a specified audience from the well educated/knowledgeable investor to clinicians and scientists in the same field of practice
- Regulatory strategy development – Determine optimal regulatory pathway for US, Canada, and European product approval
- Due diligence and valuation of new technologies
- Evaluate existing technical and clinical data
- Provide liaison with Notified Bodies and Competent Authorities
- Communicate and meet with FDA for strategic discussions
- Determination meetings with FDA (pre-IDE / pre-IND, EOP II)
- Determine pre-clinical and clinical requirements
- Down-classification petitions
- Orphan designation