Our Core Competencies

Scientific & CMC regulatory Advice

To help optimizing CMC and regulatory strategies during the entire product development, licensing and post-approval phases

Authoring and review of CMC dossiers

From clinical trials, to new marketing application to post approval variations and authorities briefing documents.

Management Support

Interim management, project management & connection and support to Technical Teams, Issue & risk management

Training & Coaching

Junior staff and/or Managers

Our Services

• Products Experience

• Scientific Expertise

• CMC Regulatory Experience

• Worldwide Regulatory Guidance and Requirements

• Management of Change Control Process and Quality Systems

• Change management

• Project & Team Management

• Non-clinical Regulatory Experience