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Our Services

World-Class R&D

At Sofgen CDMO, we work with efficiency, quality, innovation, and flexibility to support even the most challenging pharmaceutical projects.

Backed by deep expertise in pharmaceutical development, our teams are driven by science and technology to solve formulation challenges and meet technical and regulatory requirements across every stage of the product lifecycle, from early development to commercial manufacturing always under cGMP standards.

Our Services

Our R&D and development services include

Development of novel, patentable formulations.

Development of novel, patentable formulations.

Solubility screening and optimization.

Solubility screening and optimization.

Fill formulation development

Fill formulation development.

Gel formulation development.

Gel formulation development.

Gel–fill compatibility studies.

Gel–fill compatibility studies.

Small-scale encapsulation for early development and formulation selection.

Small-scale encapsulation for early development and formulation selection.

Clinical Trial Material (CTM) manufacturing.

Clinical Trial Material (CTM) manufacturing.

Process scale-up from Phase I to registration and commercial production.

Process scale-up from Phase I to registration and commercial production.

Regulatory support, including regulatory strategy, dossier preparation, and submission support to ensure quality, timely filings, and faster approvals.

Regulatory support, including regulatory strategy, dossier preparation, and submission support to ensure quality, timely filings, and faster approvals.

Post-approval support.

Post-approval support.

Lifecycle management (LCM) and line extensions.

Lifecycle management (LCM) and line extensions.

Hand holding a Unigel softgel capsule
Services

Laboratory

"Success in developing precise analytical methods"

Our success in developing precise analytical methods and delivering unmatched quality in routine analytics, gives us experience that is vital to the success of your Project integrated analytical capabilities, mixed with top-of-the-line equipment, and scientific expertise.

Analytical Testing

Analytical method development

Analytical method development, validation and testing.

Validation of Swab Methods

Validation of Swab Methods for cleaning verification.

Batch/Lot release testing

Batch/Lot release testing for APIs.