Services

Providing Everything You Need

Drug Substance Services

Experts in synthetic route design and improvement, scale-up for commercial manufacturing, fate and purge studies, and PPQ enabling and execution.

Drug Product Development

We have deep experience in developing solid oral dosage forms, sterile products, and other challenging drug delivery platforms. We can support the clinical testing materials supply management and shipping validation.

Analytical Development

We provide the phase-appropriated development of analytical methods and validation for routine QC and stability testing and other special needs such as extractables and leachables, bioassay, nitrosamines, and so on. We also support standard characterization, stability program management, shelf life projection, impurities identification and characterization, and technical transfer between vendors.

Regulatory Submission

We have experience with product approvals and IND/IMPD submissions without any review comments. We draft module 3 and support other modules to support IND to NDA applications. Our Ready to Submit(R) IND and NDA preparation saves you time and reduces the agency review cycles, which helps your product launch much earlier.

Quality Management

We have strong experience interacting with the FDA on quality management. In addition to routine quality management support, we can also provide mock quality audits for pre-approval inspections and GMP audits to support the FDA, EMA, and other global regulatory authority's inspections. We can also help you to build the phase-appropriated quality system, such as SOP drafting and quality management systems.