Product design as per ICH Q8 , 9, and Q 10 and Q 11
Quality by Design and PAT application
Assist 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 development of
Drug Product dosage forms to ensure delivery on the pharmaceutical development
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 identification of appropriate
Drug Product formulation and manufacturing platforms.
Ensure implementation of drug product platforms
through technology investments and providing technical guidance on selection
of technologies for specific drug development projects within the portfolio.