Our Process Engineers have vast knowledge built on decades of experience in the areas of Formulation, Product and Process Development, Small and Large Scale Trials, API and excipients assessments, Statistical Support, Process Validation, Packaging Validation, Cleaning Validation, Environmental Monitoring, CPV and Serialization.
Our team holds impressive track record of formulating and developing Oral Solid Dose, Semi-Solids and Liquid products to various markets and countries.
Immediate release, delayed release or bi-layer products, we have done them all and will share our experience and knowledge in all aspects of development and commercialization from documentations all the way to shop floor support.
In its former term, Process Validation, is one of the most important focal points of any regulatory inspection and submission and should be considered critical to any product.
Our team has executed PPQs of hundreds of products under different conditions, time constraint and challenges over the years and gained extensive knowledge and experience that will benefit your organization.
Our team has developed PPQ programs, Protocols, Reports, SOPs combined with Statistical Analysis over the years to support new regulatory requirements to different markets and countries.
We will provide extensive support in reducing cycle time and cost by eliminating documentation and execution redundancies.
In fact, one of our team members is a frequent guest speaker in Process Validation , PPQ and annual GMP updates and often presents and explains the methodologies developed and that have successfully passed regulatory inspections.
Our team has developed, implemented and supported CPV programs in a few organizations and have successfully passed regulatory inspections.
CPV is an expectation under the FDA 2011 Guideline and our team is in the front line supporting implementation and documentation as well as the required statistical analysis.
Automation is essential to this program success. we have proudly implemented automation in numerous organizations to support CPV programs.
Post validation activities, whether or not premised on quality issues, such as API or Excipient changes are fully supported by our team.
Our team has developed an acceptable FDA and Health Canada risk assessment combined with a process validation program to support these type of changes and will support your organization from establishment through execution to a successful implementation.
Our team has established the above programs in some of the largest pharma companies and passed regulatory scrutiny successfully.
Our team will support establishment, documentation, implementation and execution of these programs at all levels.
Our team has been in the front line since inception of the Serialization expectation and have been diligently working with key vendors, suppliers and professionals in the industry to provide the best support possible to our clients.
Our team will support serialization activities from establishment of a program through documentation and equipment configuration, implementation and execution (read more under Engineering Services)