A one stop shop to help you develop your ideas into successful medical products
We specialize in providing comprehensive services needed for healthcare products development. We specialize in clinical development, business development and regulatory consulting services to both global, well established, pharmaceutical companies as well as startup entrepreneurs. We focus on Ophthalmology and bring to the table years of accumulative experience that can catapult your path towards regulatory approval and successful market adoption.
Have a new medical technology in Ophthalmology?
Whether it is a surgical device, a novel therapeutic, a diagnostic or a drug delivery modality. Regardless of the stage of technologic development, we would work together with you to tailor a winning strategic guidance plan that would enable you to navigate towards an expedited regulatory approval, a successful market launch and most importantly- a widespread market adoption.
Every endeavor needs a strategy, so where can we help you?
Our Clients include capital backed start-up companies developing cutting edge ophthalmic assets, as well as global pharmaceutical companies looking for portfolio enrichment.
Looking for investment?
Answering your business development needs- We facilitate investment rounds for both early stage as well as late stage assets. We specialize in packaging the technology correctly to position it for success. We then build a strategic plan for investment recruitment and execute it with the organic team. We also negotiate licensing, acquisitions, strategic alliances and joint ventures.
Looking to invest in new technologies?
For larger, commercially-successful, public and private companies seeking to acquire new technologies, we perform market research, competitive landscape assessments and search and evaluation of new technologies.
Our company represents both Buyers and Sellers. We specialize in search and evaluation- identifying the right assets for investment, due-diligence, risk assessment, and strategic planning for pharmaceutical organizations.
How can we help during product development?
We provide regulatory and clinical development support, reducing costs of hiring company personnel, enabling companies maintain lean organizations.
Regulatory support- Starting with support with pre-Investigational New Drug (IND) meetings, following up with clinical trial protocol submissions, through submitting and receiving approval for the New Drug Application (NDA), to post-approval marketing activities and lifecycle maintenance.
Clinical development- pre-clinical and clinical trials protocol development; identifying and working with CROs, investigator recruitment, study implementation, auditing and monitoring trials, and preparation of final reports for a variety of clinical applications in the US and internationally.
Medical affairs- devise strategic launch plans including preceptorships; advisory boards and medical liaisons training to enable optimal adoption in the market place
Quality assurance - devise and execute systems for Current Good Manufacturing Practices (CGMP), Quality Management System (QMS), pharmacovigilance and medical device reporting and complaints systems. SOPs for manufacturing, laboratory, clinical, and document control use, Pharmacovigilance and medical device reporting and complaints
Manufacturing and operations support - strategic plans and execution for technical operations set up and transfer; operations evaluations and cost efficiencies. Supply chain management across all continents- understanding unique challenges in each market.