Pharmaceutical Development

Navigating the ever-evolving scientific, technical, and regulatory environment in the pharmaceutical industry is crucial for organizations to stay competitive. 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 scientific professionals is here to guide you through the unique intricacies of drug and pharmaceutical product creation.

Our specialists are on hand to support you right from the initial stages of development through to analytical testing and will assist in obtaining necessary product licensing and manufacturing for commercialization.

We’ll collaborate with you to create development strategies that leverage cutting-edge advancements in product development studies. Our services encompass the entire drug development cycle from lead candidate selection to managing Chemistry, Manufacturing, and Controls (CMC) challenges like formulation modifications and regulatory submission filing in Common Technical Document (CTD/eCTD) format. This comprises 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, as well as post-market activities.

Our experts’ 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 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