OUR LOCATION – The HA Valley
Located half way between the French shore of Lake Geneva and Lake Annecy, Falgagen is an innovation-driven biomedical company, expert in the conception, manufacturing, technology transfer, industrialisation, regulatory and quality affairs and marketing of Medical Devices comprising natural polymers.
Falgagen has a strong expertise in hyaluronic acid and chitosan viscoelastic solutions and gels.
OUR EXPERTISE
Our team consists of Research and Development scientists and medical device strategists, committed to provide you with the best solution, customised to your specific needs.
With a cumulated experience of more than 30 years, our team has strong knowledge and know-how in the conception of face & body fillers, joints visco-supplements, ocular viscoelastic and genital rejuvenation devices.
FRENCH EXPERTS IN DESIGNING, DEVELOPING, AND MANUFACTURING HYALURONIC ACID AND CHITOSAN VISCOELASTIC SOLUTIONS AND GELS.
OUR LOCATION – The HA Valley
Located half way between the French shore of Lake Geneva and Lake Annecy, Falgagen is an innovation-driven biomedical company, expert in the conception, manufacturing, technology transfer, industrialisation, regulatory and quality affairs and marketing of Medical Devices comprising natural polymers.
Falgagen has a strong expertise in hyaluronic acid and chitosan viscoelastic solutions and gels.
OUR EXPERTISE
Our team consists of Research and Development scientists and medical device strategists, committed to provide you with the best solution, customised to your specific needs.
With a cumulated experience of more than 30 years, our team has strong knowledge and know-how in the conception of face & body fillers, joints visco-supplements, ocular viscoelastic and genital rejuvenation devices.
FRENCH EXPERTS IN DESIGNING, DEVELOPING, AND MANUFACTURING HYALURONIC ACID AND CHITOSAN VISCOELASTIC SOLUTIONS AND GELS.
OUR LOCATION – The HA Valley
Located half way between the French shore of Lake Geneva and Lake Annecy, Falgagen is an innovation-driven biomedical company, expert in the conception, manufacturing, technology transfer, industrialisation, regulatory and quality affairs and marketing of Medical Devices comprising natural polymers.
Falgagen has a strong expertise in hyaluronic acid and chitosan viscoelastic solutions and gels.
OUR EXPERTISE
Our team consists of Research and Development scientists and medical device strategists, committed to provide you with the best solution, customised to your specific needs.
With a cumulated experience of more than 30 years, our team has strong knowledge and know-how in the conception of face & body fillers, joints visco-supplements, ocular viscoelastic and genital rejuvenation devices.
CUSTOMISED SERVICES
INNOVATION & DEVELOPMENT
We develop tomorrow’s products by improving your existing formulations or by formulating innovative solutions, tailored to your requirements. Our expertise covers a broad spectrum of areas:
- Aesthetic – Dermal filler
- Orthopaedics – Viscosupplement
- Ophthalmology – Eye health
- Gynecology – Intimate health
We brainstorm with you and conceive your future portfolio, comprising innovative and safe medical products.
We also 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.
INDUSTRIAL OPERATIONS
We accompany you with:
- Manufacturing site implementation: cleanroom organisation, 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;
- Product validation: support in writing of validation protocols/reports (process, sterilisation, transport, stability, packaging), manufacturing of development and validation batches;
- Process improvement/optimisation: design and development of dedicated equipment to automatize, increase process yield and/or improve process robustness.
INDUSTRIAL EQUIPMENT
With the objective to optimise your industrial operations, to increase manufacturing capacity, process yield and process robustness, we accompany you with:
- Equipment audit: equipment review & 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.
REGULATORY & QUALITY
- Strategy: definition of global regulatory strategy for product launch and time to market, strategy approach to implement product’s planning for certification and approval including the clinical path.
- Operational: technical file expertise, assessment for certification or approval, introduction for review of technical file by notified body or health authority, risk approach product and manufacturing process, PRRC qualification (Person Responsible for Regulatory Compliance), according to MDR 2017/745, European Authorized Representative.
- Quality: set up an ISO 13485 and MDSAP certification schedule, Quality audit to assess the Quality System according to ISO 13485 and MDSAP, Process and procedure approach for Quality System acording to MDR2017/745.
Training: MDR 2017/745, ISO13485, Risk Approach
BUSINESS DEVELOPMENT
We support your growth plans through:
- Due-diligence: organisation and coordination of strategic business, industrial, technology and regulatory due diligences or acquisitions
- In-and-out licensing: search, select and negociate products or products range to be licensed
- Strategic insights: take part to Advisory Board to draw market trends, share market knowledge, and support future product launches or strategic positioning.
MARKETING
- 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.
CUSTOMISED SERVICES
INNOVATION & DEVELOPMENT
We develop tomorrow’s products by improving your existing formulations or by formulating innovative solutions, tailored to your requirements. Our expertise covers a broad spectrum of areas:
- Aesthetic – Dermal filler
- Orthopaedics – Viscosupplement
- Ophthalmology – Eye health
- Gynecology – Intimate health
We brainstorm with you and conceive your future portfolio, comprising innovative and safe medical products.
We also 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.
INDUSTRIAL OPERATIONS
We accompany you with:
- Manufacturing site implementation: cleanroom organisation, 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;
- Product validation: support in writing of validation protocols/reports (process, sterilisation, transport, stability, packaging), manufacturing of development and validation batches;
- Process improvement/optimisation: design and development of dedicated equipment to automatize, increase process yield and/or improve process robustness.
INDUSTRIAL EQUIPMENT
With the objective to optimise your industrial operations, to increase manufacturing capacity, process yield and process robustness, we accompany you with:
- Equipment audit: equipment review & 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.
REGULATORY & QUALITY
- Strategy: definition of global regulatory strategy for product launch and time to market, strategy approach to implement product’s planning for certification and approval including the clinical path.
- Operational: technical file expertise, assessment for certification or approval, introduction for review of technical file by notified body or health authority, risk approach product and manufacturing process, PRRC qualification (Person Responsible for Regulatory Compliance), according to MDR 2017/745, European Authorized Representative.
- Quality: set up an ISO 13485 and MDSAP certification schedule, Quality audit to assess the Quality System according to ISO 13485 and MDSAP, Process and procedure approach for Quality System acording to MDR2017/745.
Training: MDR 2017/745, ISO13485, Risk Approach
BUSINESS DEVELOPMENT
We support your growth plans through:
- Due-diligence: organisation and coordination of strategic business, industrial, technology and regulatory due diligences or acquisitions
- In-and-out licensing: search, select and negociate products or products range to be licensed
- Strategic insights: take part to Advisory Board to draw market trends, share market knowledge, and support future product launches or strategic positioning.
MARKETING
- 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.
TEAM
FALGAGEN originates from a common desire of its three founders to be the first company to provide the life science industries with high quality services for boosting their competences and productivity, for building up new market opportunities and developing tomorrow’s products.
Consisting of experienced strategists, skilled scientists and engineers, our team compliments its partners with a customised approach to speed up and drive their project to achievement.
CONTACT US
LET US KNOW
HOW WE CAN
HELP YOU
Email: contact@falgagen.com
FALGAGEN
83 Impasse de la Fruitière
74350 Allonzier-la-Caille
FRANCE