Societal™ CDMO
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 in 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.
Societal CDMO: Bringing Science to Society. For more information about Societal CDMO’s customer solutions, visit
Innovative Reformulation of a Complex, High-Drug-Load, Modified Release Dosage Form With Reduced Dosing Frequency
The FDA wants you to reformulate your opioid oral controlled-release product to provide a level of abuse deterrence. A lengthy, expensive ordeal seems inevitable. But what if you could limit and position the formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance? We helped a client in exactly this position accomplish a complex reformulation and successful CMC supplement filing in less than a year. Learn more by downloading this case study.
How to Achieve Different Release Profiles and Select Excipients for Formulation Development of Modified Release Oral Solid Dosage Forms
In pharmaceutical manufacturing, the formulation and manufacture of
How to Avoid Last Minute CMC Roadblocks to Approval
It’s tempting to minimize or defer CMC activities while preparing for clinical milestones. Are you making decisions that may delay — rather than accelerate — development? Steer clear of: “We have to start over” by reading this white paper.
Is Wurster Processing the Right Choice for My Multiparticulate Modified Release Dosage Form?
Wurster processing is a versatile pharmaceutical development and manufacturing technique for multiparticulates in
Newsletter
Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.
