USDM Life Sciences helps ease the regulatory burden on cannabis and CBD product manufacturers. Dozens of countries already have regulations in effect today. U.S. regulatory agencies are discussing how to
regulate the industry, and other countries are not far behind.
For 20 years, USDM has worked with heavily regulated life sciences companies. We understand the challenges facing new, emerging cannabis and CBD companies. We have helped numerous cannabis customers reach commercialization faster by implementing best practice compliance programs. We also have expertise in rapidly implementing dozens of quality, content, and clinical cloud systems.
We are also working with several cannabis and CBD companies to help implement IT compliance programs and fast-track their digital transformation strategy. With our vast experience and strategic mindset, we not only address your immediate regulatory needs, but we also build scalable solutions to help future-proof your compliance needs for the continually changing global life sciences environment.
USDM can help you with:
- Developing IT Strategy and IT Roadmaps
- Establishing IT Compliance Programs
- Accelerating vendor selection, validation, and implementation of all regulated systems
- QMS, Quality Documents, Content Management, eDC, Clinical, IXRS, RIM, LMS, CTMS, eSignature, Okta, and many others
- Experts in Program Management of all GxP Cloud applications, such as Veeva, Box, DocuSign, TraceLink
- Validation of all GxP applications
- ￼Managing Changes of Cloud Applications to achieve continuous compliance
- Pre-Validated Solutions
- Organizational Change Management to drive end-user adoption (training and communications)
- Clinical study standardization including UAT
- Navigate federal and state laws to ensure compliance with both current and future regulations
- Help with government agency approval process, including the FDA and Health Canada
- Post-approval compliance and enforcement standard operating procedures (SOPs) that are GMP and ISO 9001 compliant
- Accelerating Process Maturity
- Accelerating Regulatory Readiness
- Developing and Implementing Phase-Appropriate Quality Programs
- Supplier and Software Auditing as a Service
- GxP Assessments
- Quality Transformation & Quality Culture Development
- Vendor Management Program Development
- Support to correct compliance violations
Clinical trial processes can be labor-intensive; that’s why we offer cost-efficient solutions to streamline operations through all phases of development. From clinical user acceptance testing (UAT)and validation services to faster study start-up through the use of clinical portals, USDM can provide the level of support you need to manage your clinical study successfully.
Manufacturing systems - We provide strategic planning, vendor selection, compliance and validation execution, and remediation services for manufacturing systems in support of commercialization.
Facilities and Utilities - We provide industry-proven engineering consultants experienced in multi-discipline start-up and operations activities to guide and support the planning, construction, validation, and commissioning of a green-field or re-purposed site.
USDM has a proven record of ensuring that our client's Laboratory Information Management System (LIMS) applications efficiently implement their laboratory and sample management operations to produce the information required for effective decision making, license applications, and many other critical business use cases.