Injectable Drug Product Development Services

Sterile Injectable Drug Product Development Services

MPP Group, LLC’s drug development services are designed to help you achieve your drug discovery goals. With a staff of creative and experienced research scientists, including Dr. Michael Major who has himself developed and launched FDA commercially approved generic Injectables, we offer an effective development team that can optimize your processes and develop quality drug formulation.


Our key services includes:

  • API –release test methods including assay and impurities
  • RLD – analytical methods, (pH, O2, osmolality, assay, related substances, accelerated stability)
  • DRUG PRODUCT –  HPLC, GC, GC/HS/MS, LC/MS/MS, UV-Vis, formulation parameters, compatibly to packaging materials, preliminary forced degradation studies, terminal sterilization, identification of critical parameters, (pH, O2, temp., light), leachables, osmolality, particle size, titration, ROI, etc.
  • MICROBIOLOGY – bioburden, sterility, bacterial endotoxin, microbial retention of sterile filters, flushing volume, bubble point ratio test.

Our Instruments








Moisture Analyzer


Our approach is to identify the appropriate formulation, followed up by executing the necessary analysis and method validation. Our experienced team will develop your formulation in our cGMP lab fully supported by our state of the art in-house analytical instrumentation ensuring you have the best data and a short turn-around time to allow for quick decision making in your development process.

Let MPP Group, LLC be your partner in product approval support from development to validation of your next sterile injectable drug.

Please fill out the form below to request a proposal. MPP Group, LLC would be pleased to have the opportunity to assist you in your needs.

Injectable Drug Product Development Services Inquiry

Keeping ahead of COVID-19

This rapidly evolving coronavirus (COVID-19) has imposed an unsettling, fluid situation upon our community and its businesses. As we learn more and more about COVID-19 and the disease it causes, we want to share with you the preparations that we have undertaken to protect the interests of our clients and our employees. We take extremely seriously our responsibility to provide our clients and our colleagues a safe, healthy and secure business environment. to that extent, we have stepped up our sanitation procedures and are disinfecting all areas one a daily basis. Our business continuity plans provide colleagues the ability to work at remote locations, including their homes. We are certain to learn more in the next few weeks about this coronavirus and the impact on the health of our clients and colleagues, on our society and on the global economy. We commit to you that we will take whatever steps are necessary as a business and to do so in a fully transparent manner.