CONCEPTION

WE ARE DEVELOPING THE NEXT GENERATION PRODUCTS BY IMPROVING EXISTING FORMULATIONS OR CONCEIVING INNOVATIVE SOLUTIONS TAILORED TO THE NEEDS OF OUR CLIENTS.

• Formulation & Portfolio audit;
• Formulation & Process conception: We brainstorm with our customers and conceive their future portfolio, comprising innovative and safe medical products;
• Product development: We develop new products according to customer’s specifications;
• Formulation improvement;
• Analytical services: pH – Osmolarity – Ejection Force – Rheology (viscosity and elasticity)
• We ensure to set up a strong partnership with academic and private partners, as well as physicians, to develop and evaluate your new formulations in vitro and in vivo;
• We process all manufacturing steps from lab scale to pilot scale: 0 – 5’000 ml (ISO 5 conditions possible, under laminar flow).

INDUSTRIALIZATION: OPERATIONS

WE CAN SUPPORT OUR CLIENTS FROM THE SET-UP OR OPTIMIZATION OF A PRODUCTION SITE TO PRODUCT VALIDATION THROUGH THE DEVELOPMENT OF A DEDICATED MANUFACTURING PROCESS.

• Manufacturing site implementation: cleanroom organization, equipment selection, support to qualification, selection & qualification of a CMO;
• Development of a dedicated manufacturing process: prototyping, process development of biphasic or monophasic crosslinked HA, non-crosslinked HA formulations, team training and know-how transmission;
• Industrialization: support to the implementation of manufacturing process from lab-scale to industrial-scale;
• Know-How transmission: operators & engineering team training via theoretical and operational modules, set-up with a CMO or for a second source;
• Product validation: support in writing of validation protocols/reports (process, sterilization, transport, stability, packaging), manufacturing of development and validation batches.

INDUSTRIALIZATION: PROCESS AUDIT & IMPROVEMENT

EXTENSIVE EXPERIENCE OF MANUFACTURING SITE AUDIT (CUSTOMERS FACILITIES OR VIA TECHNICAL DUE DILIGENCES – BOTH LINEAR & CROSSLINKED HA.

• Identification of the gaps / improvements: review of the manufacturing documents,  the manufacturing site organization (clean rooms, flows, etc), the equipment in place, the manufacturing process.

• Advice to improve the manufacturing process:
  • Robustness / Batch-to-batch consistency
  • Yield
  • Ergonomic
  • Capacity / Scale up
  • Synthesis steps Automatization (partial or full automatization

• Selection / design of new equipment

INDUSTRIALIZATION : EQUIPMENT

WE ACCOMPANY OUR CUSTOMERS WITH THE OBJECTIVE TO OPTIMISE INDUSTRIAL OPERATIONS, TO INCREASE MANUFACTURING CAPACITY, PROCESS YIELD AND PROCESS ROBUSTNESS THANKS TO OUR RECENT ACQUISITION OF VORTEX, A LEADING EXPERT IN CUSTOMIZED INDUSTRIAL EQUIPMENT.

• Equipment audit: equipment review, equipment evaluation;
• Equipment recommendations: Definition of equipment needs according to commercial & industrial plans, recommendation of equipment references and equipment manufacturers;
• Equipment Design & Development: customized equipment integrated in your process, full automatization of all the synthesis steps (from solubilization to a bulk gel ready to be filled in syringes up to 25-30L batches).

MARKETING

WE SUPPORT YOUR MARKETING TEAM THROUGH:

• Market studies;
• Strategic: preparation and definition of marketing & strategic plans, product management, branding & communication strategy
• Operational: launch plans & activities, projects management, marketing tools creation, selling support tools creation, digital marketing, events management, team training and building, optimization and follow-up of operational marketing activities,
• Marketing audit: review of marketing activities and recommendations

GROWTH SUPPORT

WE ARE CAPABLE OF GUIDING OUR CLIENTS AND PROVIDING STRATEGIC SUPPORT IN AREAS RELATED TO MARKET ENTRY AND SUPPORTING THEIR GROWTH PLANS THROUGH DUE DILIGENCE, LICENSING AND STRATEGIC ANALYSIS: 

• Due-diligence: organization and coordination of strategic, business, industrial, technology and regulatory due diligences of acquisition for VC, PEs…
• Strategic insights: take part to Advisory Board to draw market trends, share market knowledge, to support future products launch or strategic positioning;
• Training Academy: Fast track training on HA markets (CEO, CFO, CCO, CMO on-boarding…);
• Competitive Intelligence

CONCEPTION

WE ARE DEVELOPING THE NEXT GENERATION PRODUCTS BY IMPROVING EXISTING FORMULATIONS OR CONCEIVING INNOVATIVE SOLUTIONS TAILORED TO THE NEEDS OF OUR CLIENTS.

• Formulation & Portfolio audit;
• Formulation & Process conception: We brainstorm with our customers and conceive their future portfolio, comprising innovative and safe medical products;
• Product development: We develop new products according to customer’s specifications;
• Formulation improvement;
• Analytical services: pH – Osmolarity – Ejection Force – Rheology (viscosity and elasticity)
• We ensure to set up a strong partnership with academic and private partners, as well as physicians, to develop and evaluate your new formulations in vitro and in vivo;
• We process all manufacturing steps from lab scale to pilot scale: 0 – 5’000 ml (ISO 5 conditions possible, under laminar flow).

INDUSTRIALIZATION: OPERATIONS

WE CAN SUPPORT OUR CLIENTS FROM THE SET-UP OR OPTIMIZATION OF A PRODUCTION SITE TO PRODUCT VALIDATION THROUGH THE DEVELOPMENT OF A DEDICATED MANUFACTURING PROCESS.

• Manufacturing site implementation: cleanroom organization, equipment selection, support to qualification, selection & qualification of a CMO;
• Development of a dedicated manufacturing process: prototyping, process development of biphasic or monophasic crosslinked HA, non-crosslinked HA formulations, team training and know-how transmission;
• Industrialization: support to the implementation of manufacturing process from lab-scale to industrial-scale;
• Know-How transmission: operators & engineering team training via theoretical and operational modules, set-up with a CMO or for a second source;
• Product validation: support in writing of validation protocols/reports (process, sterilization, transport, stability, packaging), manufacturing of development and validation batches.

INDUSTRIALIZATION: PROCESS AUDIT & IMPROVEMENT

EXTENSIVE EXPERIENCE OF MANUFACTURING SITE AUDIT (CUSTOMERS FACILITIES OR VIA TECHNICAL DUE DILIGENCES – BOTH LINEAR & CROSSLINKED HA.

• Identification of the gaps / improvements: review of the manufacturing documents,  the manufacturing site organization (clean rooms, flows, etc), the equipment in place, the manufacturing process.

• Advice to improve the manufacturing process:
  • Robustness / Batch-to-batch consistency
  • Yield
  • Ergonomic
  • Capacity / Scale up
  • Synthesis steps Automatization (partial or full automatization

• Selection / design of new equipment

INDUSTRIALIZATION : EQUIPMENT

WE ACCOMPANY OUR CUSTOMERS WITH THE OBJECTIVE TO OPTIMISE INDUSTRIAL OPERATIONS, TO INCREASE MANUFACTURING CAPACITY, PROCESS YIELD AND PROCESS ROBUSTNESS THANKS TO OUR RECENT ACQUISITION OF VORTEX, A LEADING EXPERT IN CUSTOMIZED INDUSTRIAL EQUIPMENT.

• Equipment audit: equipment review, equipment evaluation;
• Equipment recommendations: Definition of equipment needs according to commercial & industrial plans, recommendation of equipment references and equipment manufacturers;
• Equipment Design & Development: customized equipment integrated in your process, full automatization of all the synthesis steps (from solubilization to a bulk gel ready to be filled in syringes up to 25-30L batches).

MARKETING

WE SUPPORT YOUR MARKETING TEAM THROUGH:

• Market studies;
• Strategic: preparation and definition of marketing & strategic plans, product management, branding & communication strategy
• Operational: launch plans & activities, projects management, marketing tools creation, selling support tools creation, digital marketing, events management, team training and building, optimization and follow-up of operational marketing activities,
• Marketing audit: review of marketing activities and recommendations

GROWTH SUPPORT

WE ARE CAPABLE OF GUIDING OUR CLIENTS AND PROVIDING STRATEGIC SUPPORT IN AREAS RELATED TO MARKET ENTRY AND SUPPORTING THEIR GROWTH PLANS THROUGH DUE DILIGENCE, LICENSING AND STRATEGIC ANALYSIS: 

• Due-diligence: organization and coordination of strategic, business, industrial, technology and regulatory due diligences of acquisition for VC, PEs…
• Strategic insights: take part to Advisory Board to draw market trends, share market knowledge, to support future products launch or strategic positioning;
• Training Academy: Fast track training on HA markets (CEO, CFO, CCO, CMO on-boarding…);
• Competitive Intelligence

NOXELIS is a French company specializing in ophthalmic medical devices, based in Annecy, dedicated to the development of next-generation treatments containing polymers and Hyaluronic Acid. Through its technological platform, Noxelis offers various innovative formulations to treat ocular surface diseases.

Founded by a team of passionate experts, Noxelis is committed to bringing innovative technologies to market with a single goal: to enhance the ocular comfort of patients suffering from dry eye.

LEVARD is a French company located near Annecy, dedicated to designing products that enhance the physical health of athletes, enabling them to perform confidently and providing support in their athletic endeavors.

At Ledvard, we believe that muscle power is not beneficial if mobility and joint function are restricted.

We leverage our scientific expertise to enhance your performance.