Regulatory and Litigation Services

Marin Biologic also offers services to meet the regulatory needs and demands associated with Phase II and Phase III clinical trials. We offer a broad range of services and have a diverse range of clients from law firms seeking patent protection to those clients who are in various stages of their drug development process.  Our experts have years of experience working with clients and those entering Phase II and III clinical trials specifically to navigate you through the complex, regulatory challenges of the drug approval process.

Litigation Services
We are Marin Biologic have helped other pharmaceutical and biotechnology companies to protect and defend their patents.

  • Add value (product equity) to your drug by success-fully defending against litigation
  • Benefit from a cost-effective contract research team to work with your legal advisors to perform scientific research.
  • Increase your odds of winning by working with an experienced and flexible litigation-support scientific research team.

Marin Biologic has been able to aid law firms involved in patent litigation to successfully prove their case. Written and electronic records and emails are kept to a minimum, if needed, and do not contain conclusions, suggestions or opinions if directed by our legal clients.

We have been asked to:

  • Reproduce the science cited in a patent, or
  • Reproduce the science practiced by the defending company.
  • Reproduce the science using the technology of the times, rather than the current state of the art technology,
  • Testify in open court or in depositions

We have worked with client attorneys for successful presentations. Of course, as with all the projects at Marin Biologic, we treat every client and project with the utmost confidence.

Clinical regulatory support

Our clinical regulatory professionals have years of experience creating protocols that can be finalized quickly and we offer resources to readily meet the compliance and regulatory demands of your project. Along with our scientist, project leader, and regulatory teams, Marin Biologic collaborate with you so that your study is at pace or even ahead of schedule. We offer all these services as early as the Pre-Clinical, Investigational new drug (IND) and new drug application (NDA), to the submission of your new drug approval. We want to be your experts and navigate you through the process when asked to work with the FDA or other regulatory agencies. Our goal is to be your partner throughout all stages of your drug development, to support and guide the client through each step of the process, and to provide overall efficiencies to your project.

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