Overview:
yet2’s client is seeking innovation partners in North America and Europe with a range of manufacturing capabilities and capacities. This project is seeking partners with specific capabilities in developing and producing professional products for dentists’ use.
CDMOs must:
- Have manufacturing location(s) in the North America and/or Europe
- Demonstrate expertise in formulation development, compounding, manufacturing, filling, packaging, testing and R&D capabilities to produce dental products classified as cosmetic, medical devices (risk class I, II, III or IV) and drugs/medicines.
- Products may include, but are not limited to:
- Varnishes
- Desensitizing paste
- Mouthwash
- Whitening compounds and devices
- Filling capabilities should include:
- Syringes
- Syringes with dips
- Bottles
- Tubes packages
- Single dose cups
- Sachets
- Products may include, but are not limited to:
- Must comply with well-recognized quality management standards and have active registrations with local regulatory agencies
- North America:
- must follow GLP and GMP, have safety and efficacy protocols, have acceptable audits by the FDA, and be registered with the FDA.
- Europe:
- Medical Devices: Manufacturing Site certified ISO 13485: 2016.
- Medicinal Product: a site granted with a Manufacturing Authorization document and a valid certificate of GMP compliance.
- North America:
- Work in an agile and responsive way, accelerating product development and innovation.
Possible Solution Areas:
- Professional oral care
- Dental products
- Dental devices
- Contract formulation development
- Fill & Finish
- Packaging innovation
- Product format innovation
Desired outcome of the solution:
Partners able to work at various phases of product development, from innovation to prototyping & manufacturing.
Related Tech Needs:
- Seeking: LATAM Professional Oral Care Manufacturing Partners
- Seeking: CDMOs to Produce a Generic Version of a Professional Oral Care Product
- Seeking: Untraditional Oral Care Product Formats