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
Services
Design (Formulation & Product Design)
Target product profile development, formulation selection, and dose form design for oral solids, oral liquids, topicals, and inhalation products.
Develop (Preformulation, Formulation & Analytical Development)
Preformulation studies, prototype screening, process design, analytical method development, and stability testing to prepare products for clinical manufacture.
Manufacture (cGMP Clinical and Commercial Manufacturing)
Phase-appropriate cGMP manufacturing from small clinical batches through commercial production of oral solids and liquids, with integrated on-site packaging and serialization.
Analytical & Stability Services
On-site analytical development, QC testing, stability study management, and method validation across spectroscopy, chromatography, dissolution, moisture, and physical testing.
Powders for Inhalation (Particle Engineering)
Feasibility, formulation screening, particle engineering, inhalation-specific analytical testing, device and packaging selection, and scale-up for spray-dried inhalation powders.
Technology Transfer
Cross-disciplinary transfer planning and execution including analytical method transfer, equipment and facility alignment, documentation, and regulatory strategy support for commercial handoff.
Design (Formulation & Product Design)
Target product profile development, formulation selection, and dose form design for oral solids, oral liquids, topicals, and inhalation products.
Develop (Preformulation, Formulation & Analytical Development)
Preformulation studies, prototype screening, process design, analytical method development, and stability testing to prepare products for clinical manufacture.
Manufacture (cGMP Clinical and Commercial Manufacturing)
Phase-appropriate cGMP manufacturing from small clinical batches through commercial production of oral solids and liquids, with integrated on-site packaging and serialization.
Analytical & Stability Services
On-site analytical development, QC testing, stability study management, and method validation across spectroscopy, chromatography, dissolution, moisture, and physical testing.
Powders for Inhalation (Particle Engineering)
Feasibility, formulation screening, particle engineering, inhalation-specific analytical testing, device and packaging selection, and scale-up for spray-dried inhalation powders.
Technology Transfer
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