- Selection of dosage form.
- API and excipient compatibility studies.
- Definition of qualitative and quantitative formulas.
- Design of the manufacturing method.
- Establishment of in-process controls.
- Transfer of manufacturing process technology to the client.
|Categories||Contract Services - Contract Services|
|Selling Points||Experienced Technicians; International Approvals/Standards; Quality Service|
More products from Idifarma Des. Farmaceutico. S.L.
Contract Development Services
At Idifarma we are specialists in the
comprehensive management of pharmaceutical development projects. We carry out
all the experimental, documentation and consulting work, from finding a
supplier of active substance to the elaboration of the registration dossier of
a pharmaceutical product.
Idifarma’s analytical development services
include the following activities:
- Solubility studies in different media (organic, aqueous and different PH levels).
- Characterization of the thermal profile and identification of polymorphic forms by DSC.
- Impurities profile characterization.
Idifarma’s GMP plant is authorized for the
manufacturing of solid oral dosage forms of both non-potent and highly potent
drugs (cytostatic, cytotoxic, hormonal, hormone inhibitors) for clinical and
commercial use. Also we can manufacture placebo for clinical trials.
This authorization allows u...
Low solubility and low bioavailability problems are more and more frequent today in pharmaceutical development projects, and that is why Idifarma invested in Spray Drying as a suitable technological solution.
We have a complete Spray Drying suite comprised of a lab-scale Buchi B290 and a&...
With our experimented analytical staff with a
broadly equipped laboratory we can analyze products of different
pharmaceutical finished dosage forms developed or GMP manufactured by us. We
have an in-house microbiology laboratory.
Idifarma can perform:
- ICH stability studies (in controlled temperature and humidity conditions according to ICH – climatic zones I to IV).
- Photostability studies to evaluate the resistance to light radiation.
- Studies of stability in use to determine periods of use in multidose or reconst...
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