Business Development
Business development & due diligence
Our business development consulting services begin with an in-depth analysis of your firm. We take a hard look at your business to identify business development gaps and opportunities.
Development strategy
Designing strategies aligned with your company attributes and agencies requirements.
Due diligence
Preparing checklists.
Information gathering.
Analysis.
Regulatory affairs
Regulatory compliance
We provide executive regulatory consulting services that ensure regulatory compliance and unlock capabilities of your products from development to post-market.
Technical documentation : implementing, updating, upgrading.
Clinical development : effective insights on your clinical development program.
Labelling : end-to-end support for the entire labeling process.
Promotional material:
Conformity assessment.
Compliance solutions.
Quality affairs
Inspection, Audit, QSM
We support you for the proper functioning and improvement of your quality system in compliance with current legislation and best practice standards: GxP, MDSAP, ISO 13485 , ISO 9001, ISO 22000, HACCP.
Inspection
Preparation to inspections.
Being your quality representative.
Helping you answering to NCs.
Audit
Testing your QMS through internal audits.
Carrying out audits of third parties.
Quality systems management
Setting up and developing with you your QMS that complies with selected standards or regulations.
