Business Development
Business development & due diligence
Our business development consulting services starts with an in-depth analysis of your firm. We conduct a rigorous assessment to pinpoint critical growth gaps and uncover strategic opportunities.
Development strategy
Designing strategies that align your core capabilities with agency objectives and acquisition timelines.
Due diligence
Developing customized due diligence frameworks and checklists.
Systematically gathering and validating critical information.
Performing in-depth analysis to assess risk and validate opportunity.
Regulatory affairs
Regulatory compliance
From initial development through post-market surveillance, our executive consulting ensures full compliance while accelerating the commercial potential of your products.
Technical documentation: development, maintenance, and optimization of all required technical dossiers and design history files.
Clinical development: Actionable insights to design efficient and effective clinical programs.
Labelling: end-to-end support for the entire labeling process.
Promotional material: end-to-end support for compliant labeling, advertising, and promotional material review.
Quality affairs
Inspection, Audit, QMS
We support you for the proper functioning and improvement of your quality system in compliance with current legislation and best practice standards: GxP, MDSAP, HACCP, ISO Standards : ISO 13485 , ISO 9001, ISO 22000.
Inspection Readiness & Support
Minimize risk and maximize confidence during regulatory inspections.
Proactive Preparation: Comprehensive gap analyses and mock inspections.
On-Site Partnership: We act as your expert quality representative during inspections.
Finding Resolution: Strategic support in responding to and closing Non-Conformances (NCs).
Audit
Gain objective insights into your Quality Management System (QMS) and supply chain.
Internal Audits: Independent assessments to verify compliance and identify improvement opportunities.
Supplier & Third-Party Audits: Ensure your critical vendors and partners meet required standards.
Quality systems management
Setting up and developing with you your QMS that complies with selected standards or regulations.
Design & Implementation: Establishing tailored QMS frameworks from the ground up.
Development & Optimization: Enhancing existing systems for greater effectiveness and value.
