We work side by side with our partners through every step: from the formulation to the production and registration with the competent authorities.
The formulation begins with a thorough research of innovative raw materials, which are then closely analysed. They are examined with respect to their technical and safety features, and our work is supported by in-depth scientific literature. All materials are purchased from certified suppliers.
- Tablets with cosmetic film coating
- Tablets with gastro-resistant film coating
- Prolonged-release multi-layered tablets
- Hard gelatine capsules
- Gastro-resistant hard gelatine capsules
- Powders and gels for oral use (in sachets)
- Powder products (in tubs)
- Gel products
- Monophasic and biphasic single-dose vials
- Oral solutions
- Single dose vials
- Impregnated granules and corpuscles
- Hydroalcoholic solutions (mother tinctures) and glycerinated macerates
(Regional Register registration number α IT 000105FE)
- Production
- Immediate and outer packaging
- Blister packaging
- Vial packaging
- Single-dose strip packaging
- Sachet packaging
- Folding carton packaging
- Labelling
- Sleeve packaging
- Thermoformed packaging
At Alfa Omega we use climatic chambers to perform accelerated and long-term stability testing in order to establish a product’s shelf life.
- Assistance in drafting the text for cartons and labels, in accordance with Regulation (EU) 1169/2011 and D. Lgs. 169/2004
- Barcode request and product entry in databases
- Assistance in drafting package inserts and scientific/ information material
- Assistance in registering the product with the
- Ministry of Health (new disclosure, change of disclosure, ministerial deficiency letters management)
- Consultancy concerning regulatory protocols for import and export operations and applications for
- Certificates of Free Sale (CFS)
- Drafting of data sheets
- Physicochemical Testing
- Microbiological testing
- Sterility testing
