INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • Oral dose development, manufacturing, packaging, and serialization under one quality system, supporting potent and controlled compounds from clinical supply through commercial launch.

  • Inno4Life, part of the Dec Group, has in-depth knowledge and containment equipment solutions for the aseptic/sterile Fill-Finish pharmaceutical industry. In line with ISO 14644, including monitoring of viable and non-viable monitoring to comply with the most recent revisions of the ISPE containment specifications cGMP and GAMP5 guidelines.

  • Partner with Natoli Scientific during the earliest stages. Our scientific expertise with state-of-the-art analytical capabilities is ready to take any preformulation challenge.

    Natoli scientific has an expertise of handling a wide range of APIs for the development of oral solids. We apply principles of ‘Quality by Design’ to define Critical Material Attributes (CMA), Critical Process Parameters (CPP), Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP). Because we believe that understanding material and process as much as possible in the early life cycle of drug product development program is an insurance for further development path. Keeping your practices up to date with the ICHQ8 regulatory guidance issued by the US FDA. This is also a gate way for a smooth ride of product in the different stages of product development stages.

  • The LAF Downflow Booth provides product and personnel protection during the weighing or sampling of powdered substances through precise air circulation.

  • Scalable oral dose manufacturing, advanced containment, technology transfer expertise, and integrated support help reduce risk and ensure seamless progression to global commercial supply.