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.
Formulation Studies
Our pharmaceutical Development services include formulation development for a wide range of molecules, including controlled substances, small chemical, and large protein molecules…
Generics Development
Generic drugs play a pivotal role in the pharmaceutical industry, making up more than 80% of all prescriptions. They are equivalent to approved brand-name drugs, but cost around 85% less…
Generics Development
Generic drugs play a pivotal role in the pharmaceutical industry, making up more than 80% of all prescriptions. They are equivalent to approved brand-name drugs, but cost around 85% less…
Freeze Dry / Lyophilization
Synergy Bioscience has extensive expertise and state of the art equipment to develop lyophilized / Freeze Dry preparations with expanded capabilities that will meet your product’s…
Cell and Gene Research
As an alternative treatment for many diseases, cell and gene therapy has been getting better and better as technology has moved forward. We can help you with your work at Synergy Bioscience…
Cell and Gene Research
As an alternative treatment for many diseases, cell and gene therapy has been getting better and better as technology has moved forward. We can help you with your work at Synergy Bioscience…
Nanomedicine
There have been big changes in all parts of how drugs are given and how they are treated. Now, scientists are always “on the move” to find safer, more effective, and more efficient ways…
Stem Cell Research
At Synergy Bioscience, we are committed to advancing the frontiers of medicine through our leading-edge stem cell research and development. With a foundation of highly qualified scientists…
Stem Cell Research
At Synergy Bioscience, we are committed to advancing the frontiers of medicine through our leading-edge stem cell research and development. With a foundation of highly qualified scientists…