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Contract Service Directory
GLOBAL Regulatory Writing & Consulting
Company Headquarters
14900 Interurban Avenue South
Suite 271, PMB 98
Seattle, WA 98168
United States
Company Description
We provide Sponsors and CDMOs with unparalleled consulting, writing, and eCTD publishing services. Our world-class scientists and regulatory experts can guide your product from inception to bedside and through the many technical, quality, and regulatory development hurdles along the way. We apply our knowledge of health authority requirements, our technical acumen, and industry best practices to prepare technical and regulatory documents that are fit for purpose, scientifically sound, and aligned with agency requirements.
Contract Service Directory
- 505(b)(2)
- Analytical Methods Development
- Analytical Validation Studies
- Assay Development
- Auditing
- Bioanalytical Services
- Biologics Process Development
- Bioprocess Validation
- Bioprocessing
- Biosimilars
- CMC (Chemistry, Manfacturing & Controls)
- Consulting
- Consulting, Audits & Inspections
- Consulting, Process Analytical Technology (PAT)
- Consulting, Process Excellence
- Consulting, Quality Management Systems
- Consulting, Records Management
- Consulting, Regulatory
- Consulting, Talent
- Custom Protocols
- DMF Establishment / Maintenance
- Documentation Support Services
- Drug Development Services
- GMP Auditing
- IND/NDA Submissions
- Methods Development
- Methods Validation
- Process Characterization
- Process Development/Scale-Up Services
- Process Validation Studies
- Project Management
- QA/QC
- Regulatory Affairs Consultants
- Scale-Up
- Technology Transfer
- Training
- Training: cGMP/HPB/FDA Compliance
- Validation, Manufacturing
- Validation, Services
