Synogen helps young and growing companies succeed, bringing decades of experience as experts and entrepreneurs in the fields o f tech, medtech, greentech and biotech.
The broad range of expertise of the team – including engineering, regulatory, medical technology, biotech, finance and business, marketing and intellectual property – brings unique opport unities to the companies with whom we work.
We can assist our partner companies with negotiations of licensing agreements, including both in-licensing of technology from universities and research institutions and out-licensing of rights for manufacture, distribution or use. While our services do not supplant the need for an attorney to craft or review final legal agreements, our experience with biomedical technology licensing means our partner companies will know what is standard in these types of agreements and what is not.
Our assistance can either be indirect, where we offer advice and guidance in the negotiations, or direct, where we negotiate on behalf of the company. Either way, you benefit from the years of experience we bring to the table.
We can guide our partner companies to multiple sources that can provide cost-effective market research where needed.
These sources can provide comprehensive marketing research of issues, trends, revenues, growth rates, and competitive forecasts. They can provide third-party or interview-based assessments of emerging medical markets, designing, conducting, analyzing and presenting consumer research data.
These steps can help the company create an effective and efficient product development and marketing strategy.
Synogen’s team members have decades of cross-disciplinary experience bringing products to markets. Our team can assist in ensuring that clients understand all the various risks and hurdles that will likely be encountered, from regulatory, quality and materials to customers, competitors, legal and IP. We partner with the executive management of the companies we assist, providing advice and input to them in their decision-making. Our team can also provide mentoring services on a routine basis to members of the company's management team, helping them to make the best decisions and to lead most effectively.
Synogen's consulting regulatory Associates can assist our partner companies in the development of comprehensive regulatory plans. This helps assure that the company can bring its products or technologies to market as quickly as possible, minimizing unexpected issues related to FDA approval and compliance.
They have direct contacts and relationships with the FDA, and can tap those resources to understand in advance what the FDA will need to approve certain devices, drugs, biologics or systems. They can assist with Good Manufacturing Practices (GMP/cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Tissue Practices (GTP) as part of operation as an FDA-regulated business.
In general, they can give guidance in validation and regulatory compliance in the pharmaceutical, medical device and biotechnology industries.
Synogen has a large and growing number of scientific and technical experts as Advisors, who can be tapped as needed by our partner companies in a consulting relationship. The expertise of these Scientific Advisors spans many disciplines, including most major areas of the biological and life sciences.
While most of these Advisors are available to be engaged by a partner company on an as-needed consulting basis, in cases where a particular expert may be needed for extended and extensive involvement with the partner company we can arrange for that involvement to be provided on an equity basis, at the partner company's option, to conserve cash resources.
The Synogen team will work with our client companies to uncover and develop a compelling and comprehensive strategic plan. Companies who want to create mid-term and long-term success need to consider many elements, including the underlying science, the various ways that existing and emerging technologies will impact the market, how competition will likely respond to the company and to the changing market in general, how the company's competitive advantages can be preserved and enhanced in changing markets, and what impact the financial markets and the company's financial capabilities will have on outcomes. All these factors and more come together to help a company create a strategic plan that will serve management well in building for the future.