FDF / DRUG PRODUCTS COSMETICS NUTRACEUTICALS SERVICES in Europe
Contract Service Unit of a Swiss Biopharmaceutical Company that identifies, develops, and markets novel products in rare and ultra-rare diseases globally.
About the plant
We have a dual business model:
- we develops products for rare and metabolic skin diseases;
- through our Contract Service Unit we provide R&D and QC services to our customers.
With over 30 years of experience in R&D, more than 100 products developed, and over 200 patents, we are able to transform our customers´ strategic vision into the projects and products of their interest, providing tailor-made 360° services in a short time and at the lowest possible cost.
We do not operate a production facility, and by choice, we are not bound to a single CDMO approach. Instead, we collaborate with a broad and qualified network of CMOs, responsible for flexible and customized external production of various pharmaceutical forms, and with a selected network of CROs for the management of pre-clinical and clinical studies. This allows us to provide comprehensive support throughout the entire product development process.
We develop solid, semi-solid, and liquid dosage forms, both conventional and unconventional, across various healthcare categories: Drugs (small molecules and peptides), Medical Devices, FSMPs, Nutraceuticals, Medical Foods and Cosmetics.
Our 800-square-meter galenical and analytical laboratories allow us to perform in-house formulation testing, technical development, and set-up of new analytical methods. We can produce and package small-scale, non-GMP batches for prototypes and pre-clinical studies. We also handle GMP analytical validation, transfer, testing, and ICH stability programs.
In summary, our Contract Service Unit manages all aspects of product development by providing complete services from design to tech and analytical transfer, generating new IP rights or revitalizing old patents, offering lab-scale batch production for pre-clinical studies, and leveraging a skilled network of CMOs to rapidly scale up from clinical and pilot programs to commercial production. Our state-of-the-art laboratories manage a wide range of analytical services including method development, validation and transfer, R&D and QC testing and ICH/GMP stability programs.
Certifications
- ISO
- EMA (EU GMP)
Activity
- Oral solids / OSD, Topical, mucosal and transdermal, Tablets, Hard capsules, SoftGel capsules, Granules / Pellets, Powders, Lyophilizates, Lozenges, Gummies, Orodispersible / Sublingual films, Buccal (muco)adhesive films, Semisolid forms, Liquid forms, Patches, FDF / DRUG PRODUCTS, COSMETICS, NUTRACEUTICALS, SERVICES, Skin products, Skin care, Other skin care products, Cream / paste, Tablets, Hard capsules, SoftGel capsules, Granules / Pellets, Powders, Lyophilizates, Lozenges, Gummies manufacturing
Features
- Uses: Investigational, Preclinical, Human
- Toxicity (OEB classification): N/A
- DEA: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: EMA (EU)
Batch Size / Reactor
- Small
Services
- Development services, Manufacturing services, Analytical / QC services, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Research batches, Engineering batches, Scale-up, Pilot batches, Analytical methods development, Analytical methods validation, Analytical methods transfer
