Achieving sustainable results
Our Vision
Make a better and safer day...for patients, teams and shareholders !

Our DNA as a Quality Management Business Mentor is to help you to identify, remediate and solve your problems in order to turn them into growth opportunities. With more than 25 years of experience in the Life Sciences industries, our role is to help you and your teams to use current regulatory constraints as tools for optimization and sustainable growth.

Photo DH Under the leadership of our founder Dominique HOFF Résultat de recherche d'images pour "icone pour click on the link", our ambition is to provide you with our knowledge, skills and know-how to enable you to manage as well as possible your daily work, but also to highlight all existing opportunities (strategic or operational) and to use them as tools for Quality compliance sustainability and effective development. We put people at the heart of the solution, while taking into account regulatory and budgetary constraints.

Our ambition is to help you to make the best decisions in an ever-changing and regulated environment and to provide the best solution to make a better and safer day…for patients, teams and shareholders !

Our ambition

Use the constraints of the life sciences world as opportunities to always better care.

Use regulations to make the differences with competitors : Quality is a marketing tool!

Change the organization to fit with the business model defined (multinational, middle-small size, CMO, service provider…)

Propose compliant and sustainable solutions taking into account regulations and business needs.

Help you to carry on with your daily tasks in case of additional needs in the Quality Management field

How:
Life sciences industries seniority and expertise, including CMOs and service providers
Company and business management
Manufacturing and testing sites knowhow
Quality management expertise
Organizational changes
Large network
Drugs, API, Generics, Medical Devices, IVDs
Strategic
Visionary
Game changer
Entrepreneur / Swiss knife mindset
Influencer and negotiator
Pragmatism and selfcontrol
Resilience and courage
When:
Anticipation
Daily business
Crisis mode
What:
Missions
Strategy proposal, implementation and adjustment
Due diligences (M&A at company, brand, plant, product level for Quality topics)
Definition of the right subcontractor, partner or supplier / networking and follow-up
Organizational and processes auditing to define strengths and weaknesses of Quality Management organizations
Operational tasks optimization
Preparation, management of GxP inspections/audits
Scale up and tech transfers (clinical and commercial products)
Remediation plans and businesses developments proposals
Organizations and systems re-shaping to fit with regulations and markets needs
Support to Q decision makers
Quality Leaders mentoring
Tactical crisis management - negotiation with Management and Authorities
Inspection/audit findings management and follow-up
MedTech Swiss Authorized Representative services
Partners

In case of a specific expertise is required or if you would need additional support, we are used to work with chosen partners, moved by the same ethical way of working. Leaders never go alone!

Validation
Qualification
Artificial
intelligence
Supply
chain
QC
specific operational support
Regulatory
Affairs specific support (i.e. clinical studies)
Engineering
...