1300 Gould Drive,
Gainesville, GA 30504
United States
Company Description
Societal CDMO is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market. In addition to our experience handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia, and San Diego, California.
Contract Service Categories
Contract Services Directory
505(b)(2) |
Analytical Laboratory Services |
Analytical Methods Development |
Aseptic Processing |
Assay Development |
Blending |
Chromatography |
Clinical Analysis |
Clinical Supply Management |
Clinical Trials Management |
Clinical Trials, Phase I |
Clinical Trials, Phase II |
Clinical Trials, Phase III |
Clinical Trials, Phase IV |
CMC (Chemistry, Manfacturing & Controls) |
Cold Chain Management |
Commercial Drug Sourcing |
Comparator Drug Blinding |
Comparator Drug Purchasing |
Contract Development and Manufacturing Organization (CDMO) |
Contract Manufacturing |
Contract Packaging |
Contract Research |
Custom Manufacturing |
Custom Processors |
Custom Protocols |
Dissolution Testing |
Distribution, Clinical Trials |
Distribution, Commercial |
Dosage Form Development |
Drug Delivery Systems |
Drug Design |
Drug Development Services |
Efficacy Testing |
Encapsulation |
Feasibility Studies |
Filling, Capsule |
Filling, Vial |
Fluid Bed Processing |
Forced Degradation Studies |
Formulation Development |
Formulation Services |
Formulation, Controlled Release |
Granulation |
HPLC |
Manufacturing, Capsules |
Manufacturing, Clinical Trials Supply |
Manufacturing, Controlled Substances |
Manufacturing, Creams & Ointments |
Manufacturing, Custom |
Manufacturing, Cytotoxic & High Potency Compounds |
Manufacturing, High Containment Operations |
Manufacturing, Liquids |
Manufacturing, Oral Drug Delivery |
Manufacturing, OTC |
Manufacturing, Peptides |
Manufacturing, Powders, Non-Sterile |
Manufacturing, Solid Dosage |
Manufacturing, Solutions & Suspensions |
Manufacturing, Sustained Release |
Manufacturing, Tablets |
Methods Development |
Methods Validation |
Mixing & Blending |
Mixing and Granulating Equipment |
Packaging, Blister |
Packaging, Blister, Cold Form |
Packaging, Capsules |
Packaging, Clinical Trial Materials |
Packaging, Clinical Trials |
Packaging, Consultants |
Packaging, Glass Vials |
Packaging, Labels |
Packaging, Liquids |
Packaging, OTC |
Packaging, Pouches |
Packaging, Powders |
Packaging, Samples |
Packaging, Services, Other |
Packaging, Solid Dosage |
Parenterals, Vial Filling |
Pilot-Scale Filling |
Preclinical Testing |
Preclinical Testing Formulations |
Preformulation |
Process Characterization |
Process Development/Scale-Up Services |
Process R&D |
Process Validation Studies |
Project Management |
QA/QC |
Quality Control Testing |
R&D Services |
Raw Materials Analysis |
Regulatory Affairs Consultants |
Scale-Up |
Serialization |
Shipping |
Stability Studies |
Stability, ICH |
Sterile Filling |
Storage |
Supply Chain Management |
Tablet Coating |
Technology Transfer |
Validation, Clinical |
Validation, Manufacturing |
Content From Societal CDMO
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Co-President of Operations for Societal CDMO talks about the capabilities of the combined CoreRx and Societal CDMO businesses.
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Discusses sterile injectable and OSD capabilities, recent FDA approval to manufacture commercial tablet, and Pharma supply chain trends and challenges.
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In the pursuit of operational excellence and continuous improvement, it is important to consider the role of people and culture in driving long-term success.
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Considerations for developing modified release versions of an immediate release product.
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How an Outsourcing Partner Can Deliver Efficient Serialization Solutions
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Read this case study to see how Societal CDMO leveraged innovative processing equipment from Freund-Vector to develop an efficient — and effective — solution.