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Research and Development

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Research and Development

We take your concepts and turn them into generic drug opportunities through a robust development process, To accelerate your development pipeline, our team engages in a tested process methodology increasing product success, including:

Pre-Formulation and material science: we investigate the chemical and physical properties of the Active Pharmaceutical Ingredient (API) and excipients,

  • Pre-Formulation and material science: we investigate the chemical and physical properties of the Active Pharmaceutical Ingredient (API), excipients, and product and process contact components.
  • Product development of all dosage forms including potent products:
  1. Sterile Dosage Forms
    1. Liquid Injectables
    2. Emulsions
    3. Lyophilized Preparations
    4. Sterile Powder Filled
  2. Semi-Solid Topical Dosage Forms
    1. Ointments
    2. Lotions
    3. Topical Solutions
    4. Creams
    5. Gels
  3. Solid Dosage Forms
    1. Tablets
    2. Capsules
  • Process Development: Working directly with our contract manufacturing partners, we undertake a process review of the product and the supporting methods by testing different key process parameters in house prior to transfer, reducing risk in product scale up.
  • Technology transfer and Scale-up: Our team is actively involved in the technical transfer of the product to our contract manufacturing partner, ensuring that the product is cared for all the way through production.
  • Process optimization.

Qualified team and qualified instruments with professional planning resulted in execution analytical activities in disciplined manner. Such activities include:

  1. Method development and validation (HPLC, GC, spectrophotometric, titration, enzymatic assay).
  2. Comparative dissolution and bio-waiver reports.
  3. GC Residual solvents method.
  4. Extractables and leachables analysis.
  5. Franz cell.
  6. Elemental impurities.

  1. CTD files preparation and review.
  2. Response to deficiency letters.
  3. Monitoring and auditing bioequivalence studies.
  4. File registration and follow up.
  5. Technical opinion concerning the registrability of products or manufacturing sites through the review of the product dossiers, Drug Master Files, Site Master Files.
  6. Expert reports for clinical and nonclinical studies and summaries (CTD modules, IV & V).
  7. Periodic safety update reports (PSUR).