Ferndale Contract Manufacturing
Contract manufacturer focused on development and GMP manufacturing of topical liquids and semi-solid dosage forms (creams, lotions, ointments, gels). Services include formulation development, process scale-up, cGMP clinical trial material production, analytical method development and validation, stability testing, packaging compatibility, serialization/aggregation for supply-chain compliance, and regulatory submission support.
Industries
Nr. of Employees
medium (51-250)
Ferndale Contract Manufacturing
Services
cGMP manufacture, packaging, and labeling of clinical trial materials for any phase of development.
Formulation development and process optimization for liquids and semi-solids, including development batches, troubleshooting, impurity testing, analytical R&D, and process validation.
Development, validation, and transfer of laboratory test methods and generation of cGMP data to support regulatory submissions.
IQ/OQ/PQ qualification and validation of manufacturing processes, packaging, cleaning procedures, and software.
Packaging compatibility testing, container-closure evaluation, label design, dieline development, and preparation of print-ready files.
Compounding suites and manufacturing operations for creams, ointments, gels, lotions, and liquids with batch production and scalability to commercial volumes.
cGMP manufacture, packaging, and labeling of clinical trial materials for any phase of development.
Formulation development and process optimization for liquids and semi-solids, including development batches, troubleshooting, impurity testing, analytical R&D, and process validation.
Development, validation, and transfer of laboratory test methods and generation of cGMP data to support regulatory submissions.
IQ/OQ/PQ qualification and validation of manufacturing processes, packaging, cleaning procedures, and software.
Packaging compatibility testing, container-closure evaluation, label design, dieline development, and preparation of print-ready files.
Compounding suites and manufacturing operations for creams, ointments, gels, lotions, and liquids with batch production and scalability to commercial volumes.
Expertise Areas
- Topical semi-solid and liquid formulation
- cGMP clinical trial material production
- Analytical method development and validation
- Process scale-up and technology transfer
Key Technologies
- UPLC/HPLC (PDA, RI, UV/VIS, ELSD detectors)
- Gas chromatography (direct injection and headspace)
- Laser diffraction particle size analysis
- FTIR spectroscopy