Pharmaceutical Development

The field of analytical chemistry plays a crucial role in drug and pharmaceutical product development. As the scientific, technical, and regulatory landscape of the industry evolves, it is important for organizations to stay ahead of the curve. Whether you are a virtual company or a traditional pharmaceutical company, our team of scientific experts can help you navigate the unique challenges of drug and pharmaceutical product development.

From early-stage development to manufacturing support, our experts are equipped to assist you every step of the way. We can help you formulate development strategies that take into account the latest advancements in analytical chemistry, from lead candidate selection to managing Chemistry, Manufacturing, and Controls (CMC) issues such as formulation changes and filing of submissions worldwide in Common Technical Document (CTD/eCTD) format. This includes Pre-INDs, INDs, CTAs, BLA, NDAs, NDSs, MAAs, 510(k)s, PMAs, IMPDs, Pre-Submission Briefing documents, Investigator’s Brochures, Annual Reports, and Integrated Summaries of final regulatory submissions and post-market activities. Our experts are here to help you make the most of your investment in drug and pharmaceutical product development through their deep knowledge of analytical chemistry.

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 the 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 the commercialization purposes.
  • Develop and validate the analytical test methods needed for your pharmaceutical substance/product, whether these methods are for potency, drug substance related impurities, or residual solvents.
  • Characterize and profile extractables and leachables that might form as a result of interaction between your pharmaceutical product and its primary container.
  • Develop and implement pharmaceutical product stability indicating study and perform the product stress testing to predict drug degradation outcome and estimate the shelf life of your pharmaceutical product for the CMC sections of your product application filing.
  • Develop and validate pharmaceutical product dissolution test studies and establish the regulatory required in vitro – in vivo correlation study outcome.

In addition, virtual entities and small or emerging biotechnology, pharmaceutical and medical device companies benefit from our development expertise and experience with regulatory agencies by using our state-of-the-art laboratory capabilities and our scientific and technical staff expertise. 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 companion diagnostics.

To discuss your product needs, please contact us