• Product Development

• Product design as per ICH Q8, 9, and Q 10 and Q 11

• Quality by Design and PAT application

• Assist in improving manufacturing operations for sterile and nonsterile products

• Provide assistance to develop new product formulations for nonsterile and sterile products.

• We can provide you with the development, registration, and commercialization of drug Products for new chemical entities and/or line extensions.

• We can provide scientific/technical assistance and leadership for the departmental staff that is engaged in the development of formulations and drug product manufacturing processes for both solid oral dosage forms and parenteral dosage forms.

 

Our responsibilities can include:

• Providing strategic and scientific/technical leadership and guidance for all activities associated with the development of Drug Product dosage forms to ensure delivery on the pharmaceutical development portfolio.

• Ensure appropriate technical agendas are defined for Drug Product formulation and process development.

• Ensures cross-functional integration with Analytical, Chemical Process R&D, and Manufacturing Tech Transfer.

• Ensure projects are appropriately resourced to meet commitments.

• Ensures successful technology transfer to Clinical Trial operations and commercial manufacturing sites.

• Project updates are appropriately communicated to functional management and aligned with component business processes.

• Participate in the identification of appropriate Drug Product formulation and manufacturing platforms.

• Ensure implementation of drug product platforms through technology investments and providing technical guidance on the selection of technologies for specific drug development projects