Collaboration is in our genes. As former senior scientists in academia, industry and FDA reviewers, each of our consultant brings decades of experience working with teams as diverse as the field of biotechnology, chemistry, pharmaceuticals or medical device technology. Regardless of the scope of our engagement, our professionals strive to seamlessly integrate with your project teams, providing hands-on, proactive support and guidance every step of the way. We view ourselves as your success partner, not as an outside consultant.
Experience, innovation, determination and solution-oriented focus: these have been the pillars of success for Life Therapeutics Regulatory Consulting since our founding over fifteen years ago. Our processes are deliberate, informed and grounded in reality. We recognize that each client engagement is unique and pride ourselves on developing strategies that are comprehensive, efficient and alert to nuance. At Life Therapeutics, we work to build a consulting relationship where we can communicate and execute the projects as “partners to your success” in a candid and respectful way, allowing us to surface issues and opportunities more readily and achieve the solutions our clients have come to expect.
Whether you're a small innovator working on your first product or a large, multi-national conglomerate working on your next blockbuster breakthrough therapy, you will have our dedicated team working to support your product. With Life Therapeutics Regulatory Consulting Services we will operate as a true extension of your team and integrate ourselves seamlessly into your existing product development processes and team dynamics.
Collaboration is a cornerstone at Life Therapeutics Regulatory Consulting Services – whether we're educating one another on the latest Agency thinking or discussing how to navigate a particularly challenging scientific situation, our team is constantly sharing insights and best practices in an effort to expand our knowledge base and provide the best guidance to our clients. Our collaborative environment is driven by both our intellectual curiosity and our shared goal of providing our clients with value-added solutions to their problems.
Life Therapeutics scientific & regulatory team consist of highly talented scientists and regulatory consultants have successfully launched and marketed medical devices, BLAs, INDs, ANDAs, NDAs, 505(b)(2)s and complex generic products across a wide range of dosage forms and technology platforms. Our trained professionals have the know-how to go from selection of a lead candidate to commercially launching a product, which includes a complete product development life-cycle – a must-have in this highly competitive marketplace.
Our scientific and regulatory staff is aware of protecting your intellectual property by means of patent protection and in some cases finds ways to invent new technology in order to bring innovative products to patients in desperate need for new products in the marketplace. Our co-development model looks to partner with companies who have synergies with us, and that specifically have disruptive technologies and breakthrough innovations.
Benefits for our co-development partners are that they get our highly talented and experienced team that has great track record of leveraging our technologies, scientific and regulatory team with execution capabilities that enables us to improve the health care of millions of patients. Life Therapeutics primary objective is to improve the healthcare of millions of patients and create a better world for all.
Having provided services to clients in worldwide, our international network of FDA regulatory consultants and affiliates are able to assist clients near and far to navigate the cumbersome regulatory and product development process. From gaining access to a new market to finding a manufacturing partner with acceptable facilities, our team has the knowledge and experience to help your team get the job done right and within budget.