Patent Litigation Services

  • Analytical Chemistry Expert Services
  • Packaging Compatibility Expert Services

Contract Analytical Service Vendor Management

  • Program / Project Management
  • RFP Process Development

Quality Control / Quality Assurance / Compliance Support

  • Data Integrity and Compliance Audits to cGMPs (21 CFR Parts 210 and 211)
  • Form 483 Response Preparation / Management
  • Annual Reports / PAS / CBE x Preparation
  • OOS Investigation Documentation

Extractables and Leachables Programs

  • Project Management / Vendor Management
  • Material Change Protocols
  • Controlled Extraction Study Design
  • Extractables Identification and Data Analyses
  • Extractables Methods Development and Validation
  • Leachables Stability Program Design
  • Leachables Methods Development and Validation
  • Leachables Identification and Qualification Strategies

Regulatory Consulting

  • CMC Documentation Strategy
  • Gap Analyses
  • ​​Due Diligence Audits / Technology Assessments

SCĪO Analytical - Consulting Services

Analytical Development Program Management

  • Analytical Methods Development and Validation Protocols
  • Analytical Methods Remediation Strategies
  • Impurity and Degradation Product Identification and Control Strategies
  • Stability Study Design and Protocol Development

Lean Laboratory Implementation

  • Laboratory and Quality Process Mapping
  • Standard Operating Procedures
  • Technical Staff Development​ and Training