Societal CDMO Inc.
A contract development and manufacturing organization (CDMO) focused on small-molecule CMC development and cGMP manufacturing for oral solids, oral liquids, topicals, and inhalation products. Services span preformulation and formulation design, analytical development and stability testing, particle engineering and spray drying, clinical (Phase 1–3) and commercial GMP manufacturing, technology transfer, and integrated on-site packaging under a single quality system.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Target product profile development, formulation selection, and dose form design for oral solids, oral liquids, topicals, and inhalation products.
Preformulation studies, prototype screening, process design, analytical method development, and stability testing to prepare products for clinical manufacture.
Phase-appropriate cGMP manufacturing from small clinical batches through commercial production of oral solids and liquids, with integrated on-site packaging and serialization.
On-site analytical development, QC testing, stability study management, and method validation across spectroscopy, chromatography, dissolution, moisture, and physical testing.
Feasibility, formulation screening, particle engineering, inhalation-specific analytical testing, device and packaging selection, and scale-up for spray-dried inhalation powders.
Cross-disciplinary transfer planning and execution including analytical method transfer, equipment and facility alignment, documentation, and regulatory strategy support for commercial handoff.
Target product profile development, formulation selection, and dose form design for oral solids, oral liquids, topicals, and inhalation products.
Preformulation studies, prototype screening, process design, analytical method development, and stability testing to prepare products for clinical manufacture.
Phase-appropriate cGMP manufacturing from small clinical batches through commercial production of oral solids and liquids, with integrated on-site packaging and serialization.
On-site analytical development, QC testing, stability study management, and method validation across spectroscopy, chromatography, dissolution, moisture, and physical testing.
Feasibility, formulation screening, particle engineering, inhalation-specific analytical testing, device and packaging selection, and scale-up for spray-dried inhalation powders.
Cross-disciplinary transfer planning and execution including analytical method transfer, equipment and facility alignment, documentation, and regulatory strategy support for commercial handoff.
Expertise Areas
- CMC development
- Particle engineering and spray-dried dispersions
- Oral solid dose formulation and modified release
- Dry powder inhalation formulation and characterization
Key Technologies
- Spray drying (pilot to commercial scale)
- Amorphous solid dispersions (SDD)
- Hot melt extrusion (HME)
- Fluid-bed coating / Wurster coating
News & Updates
Company participation/exhibit at CPhI Worldwide in Frankfurt.
Event participation listed on company events calendar.
Event participation listed on company events calendar.
Announcement of expanded cGMP capabilities and new process development and manufacturing suites in Oregon to support spray drying, particle engineering, and complex oral dosage forms.
Press release announcing the addition of commercial spray drying and granulation capabilities at Georgia site.
Company participation/exhibit at CPhI Worldwide in Frankfurt.
Event participation listed on company events calendar.
Event participation listed on company events calendar.
Announcement of expanded cGMP capabilities and new process development and manufacturing suites in Oregon to support spray drying, particle engineering, and complex oral dosage forms.
Press release announcing the addition of commercial spray drying and granulation capabilities at Georgia site.