Accelerate your commercialization
USDM Life Sciences is helping cannabis and cannabidiol (CBD) product manufacturers accelerate commercialization by navigating global regulations, licensing, and IT needs.
With our vast experience and strategic mindset, we address your immediate regulatory needs and build scalable solutions to help future-proof your compliance needs for the continually changing global life sciences environment.
Implementing IT Compliance Programs, Fast-Tracking Digital Transformation
For more than 20 years, USDM has worked with heavily regulated life sciences companies, so we understand the challenges you are facing in your emerging cannabis and CBD companies. Our compliance programs are based on best practices and we have implemented dozens of quality, content, and clinical cloud systems.
When it comes to establishing IT compliance programs, USDM can fast-track your digital transformation and ensure that your systems are scalable and continuously compliant.
Commercial Regulatory Solutions for Cannabis and CBD Companies
IT Support for Cannabis Companies
Modern, compliant solutions for managing data gives you a competitive advantage. USDM has helped companies like yours with:
- Developing IT strategy and IT roadmaps
- Establishing IT compliance programs
- Accelerating vendor selection, validation, and implementation of all regulated systems, including:
- QMS, eDC, IXRS, RIM, LMS, CTMS
- Quality documents
- Content management
- Clinical (CQMS)
- and many others
- Managing all GxP cloud applications, such as Veeva, Box, DocuSign, and SharePoint
- Validating GxP applications
- Managing changes of cloud applications to achieve continuous compliance with Cloud Assurance
Your facility, equipment, processes, software, and policies and procedures are all under scrutiny in the heavily regulated cannabis industry. USDM’s expertise in validation and qualification ensures that you attain and maintain continuous compliance.
USDM can qualify, verify, and validate your systems, equipment, and processes for the GxP environment, whether on-prem or cloud-based. If you need guidance migrating to the cloud, we’ve got you covered.
USDM’s Computer System Validation (CSV) methodology aligns with Good Automated Manufacturing Practice (GAMP) best practices and includes vendor audits, validation plans, risk and impact assessments, and much more.
We are also well-versed in Computer Software Assurance (CSA) if you prefer this modernized and streamlined approach to validation.
Organizational Change Management to drive end-user adoption (training and communications)
Whether you are an emerging life science company or an established enterprise, Organizational Change Management (OCM) is an important component during transformation of any scale. For example, moving from on-prem to cloud-based systems requires significant changes in behavior and understanding in order to adopt new ways of working across business units.
Don’t leave OCM to chance. USDM can maximize the traction and trajectory of your cloud-based transition with integrated workstreams to enable organizational and individual change adoption through awareness, understanding, ability, and ownership.
Regulatory Compliance for Cannabis and CBD
Cannabis can be a tricky industry. With a wide variety of legislation from one governing body to another, you need to take the proper steps to ensure compliance with your target markets.
USDM offers a variety of services to cannabis and CBD manufacturers:
- Navigating federal and state laws to ensure compliance with current and future regulations
- Assisting with government agency approval process, including the FDA and Health Canada
- Creating post-approval compliance and enforcement standard operating procedures (SOPs) that are GMP and ISO 9001 compliant
- Accelerating regulatory readiness
- Developing and implementing phase-appropriate quality programs
- Auditing suppliers and software applications
- And much more
Want to learn more?
Contact us or read on for examples of our expertise in action:
Webinar: Cannabis: Compliance in a Rapidly Changing Industry
Blog: FDA CBD Enforcement Report Released to Congress
Blog: The Cannabis Industry; Compliance and Enforcement
Blog: Cannabis and Hemp: Understanding the Rapidly Changing Landscape
Webinar: Compliance 101 for Cannabis Companies