Preparation of applications for orphan drugs designation (EMA and FDA).
Preparation of annual reports on the development of orphan drugs (EMA and FDA).
Preparation of scientific advice applications.
Holder of marketing authorizations for medicinal products for human use.
Preparation of marketing authorization applications (eCTD / NEES format).
Preparation of expert reports (Quality / pre-clinical / clinical summary and overviews).
Submission and monitoring -up to the approval- of applications for marketing authorization, including response to objection letters from the regulatory authorities.
Preparation of documentation necessary to request changes for marketing authorization.
Preparation of the required documentation for the five-year renewals of marketing authorizations (pharmacovigilance).
Translation of product information (summary of product characteristics, leaflet, labeling).
Realization of Readability Test or consultations to groups of patients.
Materials packaging management.
|Categories||Contract Services - Contract ServicesRegulatory Affairs; 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 offers solutions in different dosage
forms with the ultimate goal of optimizing its future industrial production.
The formulation development services encompasses:
- Selection of dosage form.
- API and excipient compatibility studies.
- Definition of qualitative and quantitative form...
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&...
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