Pharmaceutical Development

If you’re an investor, a traditional or virtual pharmaceutical company looking to delve into the life sciences sector, or planning to sponsor the development and market launch of a drug product, our team of scientists is here to guide you through the unique intricacies of pharmaceutical product development.

Our services encompass the entire drug development cycle from lead candidate selection to managing Chemistry, Manufacturing, and Controls (CMC) challenges like formulation development, stability, and regulatory submission filing. This comprises INDs, BLA, NDAs, NDSs, 510(k)s, PMAs, Pre-Submission Briefing documents, as well as post-market activities.

Our profound understanding of analytical chemistry will ensure you maximize your investment in drug and pharmaceutical product development. Let us be your guiding hand in this dynamic industry landscape.

Our Pharmaceutical product development support includes

  • Developing, performing, and providing the complete documentation for the pre-formulation and formulation studies of your therapeutic chemical or biological entity, using our seasoned scientists and state-of-the-art equipment and software.
  • Developing a laboratory-scale lyophilization (freeze-dry) study that will preserve the integrity of your pharmaceutical product. We will also work with you to scale up the study for commercialization purposes.
  • Developing and validating the analytical test methods needed for your pharmaceutical substance/product, whether these methods are for potency, purity, identity, drug substance-related impurities, or residual solvents.
  • Characterizing and profiling extractables and leachables that might form as a result of interaction between your pharmaceutical product and its primary container.
  • Developing and implementing pharmaceutical product stability study and performing product stress testing to predict drug degradation outcomes and estimating the shelf life of your pharmaceutical product for the CMC sections of your product application filing.
  • Developing and validating pharmaceutical product dissolution test studies and establishing the required in vitro – in vivo correlation study outcome.

Our services span the development continuum from preclinical through post-approval and are customized to address specific development challenges of small molecules and biologics, vaccines, medical devices, and combination products.

To discuss your product needs, please contact us