Strategic Regulatory Consulting

Our team of regulatory experts ensures that your products meet all legal and procedural requirements. We handle the complexities of regulatory submissions so you can focus on bringing your products to market.

Our core service offerings are outlined below:

• Global Registration Strategy

• IND/CTA & MA Applications

• MA Transfers

• Tech Transfers

• Gap Analysis

• eCTD Dossier Authoring

• Health Authority Communications

• Dossier Due Diligence

• Complex Variation Strategy

• Temporary staffing solutions

• Submission Authoring and Publishing

• Scientific Advice preparation

• Paediatric Investigation Plan

• Orphan Designation

• Product Information & Artwork Review

• Advertising Material Review

• Organisation and Process Design

• Value Capture initiatives