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.

labo vue d'ensemble
FALGAGEN-newly-formed-Hyaluronic-Acid-Chitosan-consulting-expert-service-industry

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.

  • Do you want to develop a new product to complete your portfolio in aesthetics, ophthalmology, gynecology, or orthopaedics?
  • Do you need to improve your current formulation?
  • Are you facing manufacturing issues?
  • Do you want to increase your manufacturing capacity?
  • Do you want to improve your manufacturing process?
  • Do you want to automatize your manufacturing process?
  • Are you looking for a CMO?
  • Are you preparing an acquisition or sale of a business and need a team to perform a technological and business due diligence on HA or chitosan products?

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.

labo vue d'ensemble
FALGAGEN-newly-formed-Hyaluronic-Acid-Chitosan-consulting-expert-service-industry

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.

  • Do you want to develop a new product to complete your portfolio in aesthetics, ophthalmology, gynecology, or orthopaedics?
  • Do you need to improve your current formulation?
  • Are you facing manufacturing issues?
  • Do you want to increase your manufacturing capacity?
  • Do you want to improve your manufacturing process?
  • Do you want to automatize your manufacturing process?
  • Are you looking for a CMO?
  • Are you preparing an acquisition or sale of a business and need a team to perform a technological and business due diligence on HA or chitosan products?

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.

labo vue d'ensemble

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.

FALGAGEN-newly-formed-Hyaluronic-Acid-Chitosan-consulting-expert-service-industry
  • Do you want to develop a new product to complete your portfolio in aesthetics, ophthalmology, gynecology, or orthopaedics?
  • Do you need to improve your current formulation?
  • Are you facing manufacturing issues?
  • Do you want to increase your manufacturing capacity?
  • Do you want to improve your manufacturing process?
  • Do you want to automatize your manufacturing process?
  • Are you looking for a CMO?
  • Are you preparing an acquisition or sale of a business and need a team to perform a technological and business due diligence on HA or chitosan products?
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.
Pipette adding fluid to one of several test tubes

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

Quality control certification, checked garantee of standard of company product. Concept on virtual screen.
business2

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.
innovation-
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.

Pipette adding fluid to one of several test tubes

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.
Quality control certification, checked garantee of standard of company product. Concept on virtual screen.

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

business2

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.
innovation-

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.

Do you want to become an innovation booster and further develop your career?

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Co-founder & Chief Scientific Officer

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Co-founder & Chief Technology Officer

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Co-founder & Chief Executive Officer

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Strategic & Operational Marketing Expert

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Email: contact@falgagen.com

FALGAGEN

83 Impasse de la Fruitière
74350 Allonzier-la-Caille
FRANCE