Your Partner in Pharmaceutical Development
Curida’s development expertise covers the full service for the development of nasal and inhalation drug products (OINDP). The cGMP compliant laboratory service includes the extensive performance characterisation studies for nasal and inhalation drug products (OINDP) and other dosage forms provided with a delivery device, such as ophthalmic or topical products.
Additionally, Curida offers following services across all technologies:
- Manufacturing of investigational products for clinical studies
- Product formulation and device selection
- Development and validation of analytical and microbiological methods
- Stability studies
- Regulatory processes
- Manufacturing process development and documentation
- Tech transfer and transformation from small-scale to large-scale manufacturing
Contact us today to discuss your development needs.
For the development of generic products, Curida is able to perform the regulatory challenging in-vitro bioequivalence studies and is responsible for the relevant CMC documentation for submission to the authorities.
Preservative free, sterile nasal and ophthalmic drug products fitted with multi dose delivery devices become more and more popular. In addition to physical device performance characterisation, Curida develops and validates the microbiological protocols and assesses the microbiological integrity of the product during shelf life and in particular during the in-use period.
Coupled with the manufacturing capabilities, Curida provides a one-stop solution from development to manufacture of drug products combined with a delivery device.
Ref.
FDA Guidance for Industry Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — Chemistry, Manufacturing, and Controls Documentation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), July 2002
FDA Guidance for Industry Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Biopharmaceutics. April 2003
EMA Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, Committee for Medicinal Products for Human Use (CHMP), London, 21 June 2006