Services

Interim Leadership & Advisory

• Provide experienced interim leadership for your R&D or Analytical Development teams

• Guide strategic planning for your early- and late-phase programs

• Manage CRO/CDMOs for seamless transfer and method monitoring

Analytical Strategy Development

• Design phase-appropriate analytical control strategies for your programs aligned with regulatory expectations

• Apply Analytical Quality by Design (AQbD) principles to method development and validation

• Develop phase-appropriate methods that are fit for their intended purpose

• Build frameworks to support method lifecycle management, inclusive of documentation & technical writing for: analytical target profiles, method documents, SOPs, proposals, and reports.

Cross-Functional Alignment

• Facilitate collaboration between your Analytical Development teams and other departments to ensure product quality

• End-to-end Project Management of projects big and small

Regulatory Support

• Author and review CMC sections for regulatory submissions, including Justification of Specifications and Specifications

• Prepare teams for regulatory inspections and interactions