REGBIOPARTNERS

An Agile Team of Biotech Professionals

We combine strategic vision with a hands-on approach to help companies navigate and advance global development of biologic and small molecule drug products. Our deep and broad regulatory and drug development experience, background in science, and strong analytic, writing and management skills enable us to assess gaps, provide solutions and help build small teams.

Our Services

We provide a range of services to support your drug development needs.

Regulatory Strategy/Leadership

We can assume leadership responsibilities on an interim or long-term basis. We can lead small teams, manage health authority meetings, serve as company contacts for health authorities and provide regulatory strategy at all stages of drug development.

Regulatory Intelligence

We continuously monitor changes in global regulations and guidelines. We use multiple credible sources to cross-validate and ensure the information we generate is accurate and current. We help to integrate regulatory intelligence into a company’s overall development plan.

Regulatory Operations

We provide document management services that meet good document practices including publishing, validation, and archiving. e-CTD submissions can be done through a partnered outsider vendor service.

Regulatory/Quality GAP Assessment

We can provide in-depth regulatory and quality GAP assessments. Our experience with leading regulatory and quality departments in small companies enables us to understand regulatory/quality standards required at different stages of drug development.

Medical Writing

We can provide writing support related to a range of documents (clinical/nonclinical/CMC) required for health authority submissions/interactions, and/or review and edit company generated documents. We can manage the process for document completion and submission.

Due Diligence/Partner Assessment

We are highly experienced in preparing for diligence activities. Our background in business development and partnership management provides us with a skill-set that complements our regulatory expertise.

Why Choose Us?

We are collaborative, efficient and straight-forward. We care deeply about our clients. If our expertise can’t directly address your needs, we have a network of regulatory, quality, and drug development experts we can access and even recommend.

Expertise and Experience

Our background in science and drug development, coupled with expertise in global regulatory affairs, quality leadership, medical writing and business development provide a unique combination of experience and skill. We can also tap into a broad network of scientific and functional experts as needed.

Client-Centric Approach

We have a flexible approach to address clients needs. We can be very hands on and/or high-level. We can integrate into teams or advise independently. We can adjust the level of dedicated help over time depending on a company’s needs. We can work in very dynamic environments and adapt to evolving priorities.

Results Driven Solutions

Our ability to see the big picture and address the details enables us to work highly effectively. We understand clients’ need for high-quality output to be delivered as quickly as possible. Our working model is to be open, rigorous and efficient. We pride ourselves on providing excellent work in a cost-effective way.

Collaborative Partnership

We understand that drug development is never performed or decided in a vacuum. The best outcomes depend on an excellent team of functional experts. We thrive in team environments and understand that collaboration requires having the flexibility to learn and adjust, regardless of depth of experience and skill.

Thank you for your interest

Please reach out if you have any questions or are interested in using our services.

Heidi Petersen

Co-founder

Jessica Bockhorn

Co-founder