Our trained regulatory attorneys and compliance professionals provide actionable, effective solutions to complicated research scenarios and product development. We track the ever-changing legal and regulatory landscape to provide current, on-demand regulatory support tailored directly to you.

Whether you are a sponsor, CRO, hospital system, academic medical center, IT company, or independent researcher, Advarra Consulting’s on-demand regulatory consulting makes your research altogether better.

Experienced Project Managers

Each client works with a senior-level staff member responsible for quality oversight of services, deliverables, and communications.

Proven Methodologies

Advarra brings hard-earned insight and knowledge to your research practice and programs, customizing each solution to specific client needs.

Global Capabilities

From clinical sites to laboratories to data review and vendors, Advarra can review and provide recommendations for every touchpoint in your programs.

Drugs and Biologics

From the latest immunotherapies and gene therapy products to new indications for small molecules, Advarra helps overcome hurdles to enable research on drugs, biologics, and other products regulated by government agencies in the United States and abroad.

Medical Devices

In the often challenging and confusing medical device research environment, Advarra delivers expert guidance in international regulatory standards for medical device development and research. We specialize in research involving in vitro diagnostic products, combination products, wearables, and medical device-related cyber technology issues.

Digital Health

With medical information increasingly delivered and collected via social media, mobile devices, and cloud- and software-based platforms, Advarra is here to support your digital health innovations in wearable devices, precision medicine, mobile health (mHealth) apps, Part 11, HIPAA, and HITECH compliance.

Biospecimens

Whether your vision involves establishing and maintaining a traditional repository, facilitating identification and transfer of on-demand specimens with associated health or genetic information, or beyond, our regulatory experts offer efficient solutions to potential ethical and practical implementation hurdles to move your research forward. 

Good Practice (GxP)

Understanding clinical research requirements is crucial to remaining compliant and effectively conducting research. Advarra supports US, Canadian, and global client research endeavors through GxP auditing, training, and — where necessary — responding to an FDA Form 483 to mitigate further regulatory action.

Review-Ready Documents to Move Your Research Forward

Our consultants have decades of research experience in exciting fields — international research, biobanking and tissue procurement, laboratory assays and in vitro diagnostics, health care software applications, social-behavioral studies, investigator-initiated research, and more — and they will deliver ready-to-review documents to fit your needs.

Protocol Development

Experts with direct experience in research plan development and IRB review work with your organization to craft scientifically sound, regulatory-compliant protocols that are ready to present to any IRB.

Medical Writing

Go beyond the protocol. The Advarra medical writing team offers a full suite of IRB-tailored clinical trial documents and services, including recruitment materials, ICFs, grants, investigator brochures, and device manuals. We also develop educational websites and brochures.

Biosafety

More and more patients are seeking the opportunity to access novel DNA and RNA based therapies, often accessible only through gene therapy and immunotherapy research.

Advarra is deeply versed in the highly specialized requirements for conducting gene therapy and immunotherapy research, and our consultants have worked to support multiple programs with facility engineering, safety programs, and building robust IBC practices. We provide you with the tools you need to develop a program that is uniquely yours.

For information on Advarra’s central IBC services, click here.

IBC Rapid Start

Advarra provides a single, unified set of policies, procedures, and forms that are compliant with all regulatory requirements, as well as on-site staff training to ensure that all roles, responsibilities, and processes are understood and actionable.

Interim Staffing Support

Overcome your temporary staffing challenges with Advarra interim staffing for biosafety programs. We offer on-site or remote administrative support to assist in ensuring the effectiveness of your IBC, EH&S, and other related programs while maintaining your ability to meet applicable guidelines.

Biosafety Support

Lean on Advarra to give your organization direct, on-demand access to experienced regulatory professionals who can advise on regulations and changing guidelines, as well as provide education and staff training.

Auditing

Advarra’s biosafety program auditing and gap analysis services help ensure you have a comprehensive biosafety program compliant with all pertinent local, state, federal, and country-specific requirements.

Ready for Solutions That Are Altogether Better?

Tell us what you’d like Advarra to do for your research program.