Regulatory Affairs

Regulatory Affairs
Product Description

Our experienced Regulatory Affairs Department’s goal is to give regulatory support to our clients, both during the pharmaceutical development as well as in the preparation of reports and specific requests:
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.

Idifarma Des. Farmaceutico. S.L.

  • ES
  • 2015
    On CPhI since
  • 100 - 249
Contract Service
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Quality Service
  • Supplied from

Idifarma Des. Farmaceutico. S.L.

  • ES
  • 2015
    On CPhI since
  • 100 - 249
Contract Service

More Products from Idifarma Des. Farmaceutico. S.L.

  • Contract Development Services

    Product 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.

    We cover a wide range of products, dosage forms and technological solutions.

    We have experience developing generic and innovative drugs, as well as OTC and hybrid products. We can develop according to ICH Q8 requirements to comply with FDA authorities.
  • Analytical Development

    Product Analytical Development

    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.
    - Raw material standardization.
    - Forced degradation studies ("stress testing") of active substances.
    - Development of analytical methods for the API (richness, degradation products and residual solvents).
    - Assay method, uniformity of content and preservatives (by spectrophotometry, chromatography and potentiometry).
    - Related substances method (liquid, gas or ion chromatography).
    - Water content determination method; residual solvent method.

  • Formulation Development

    Product Formulation Development

    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 formulas.
    - Design of the manufacturing method.
    - Establishment of in-process controls.
    - Transfer of manufacturing process technology to the client.

  • GMP Manufacturing

    Product GMP Manufacturing

    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 us to provide service for the optimization of production processes, pursuing goals such as cost reduction, shrinkage reduction, timing improvement the optimization of equipment capabilities.

  • Spray Dryer

    Product Spray Dryer

    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 Gea Niro Mobile Minor in the GMP manufacturing plant, capable for working with high potent active substances. With this equipment, we can provide our clients with a comprehensive solution to solubility, stability and bioavailability problems from formulation to scale-up production, applying technologies such as micro-encapsulation, amorphization or co-precipitation.

  • Quality Control

    Product Quality Control

    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.

  • Stability Studies

    Product Stability Studies

    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 reconstitution products.
    - Ongoing stability studies on already marketed products.

  • Clinical Trial Logistics

    Product Clinical Trial Logistics

    We can offer our clients regulatory consulting and logistics management of clinical trials, a complementary service to the activities performed by CROs for clinical research: - Preparation of the Investigational Medicinal Product Dossier (IMPD).
    - Preparation of Investigator’s Brochure (IB).
    - Preparation of clinical trials applications to be submitted to Institutional Review Board / Independent Ethics Committee (IRB/IEC) or to the Competent Authorities.
    - Texts design for the labeling of Investigational Medicinal Products (IMP) according to Annex 13 of GMP.
    - Design of blinding/masking strategies for IMP.
    - Manufacturing of IMP, including placebo.
    - Labeling and packaging (primary and secondary) of IMP.
    - Storage of IMP from -80ºC to room temperature.
    - Distribution of IMP among clinical trial sites.
    - Management of the return, accountability and destruction of medication used in clinical trials.

Idifarma Des. Farmaceutico. S.L. resources

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