We provide a comprehensive range of cGMP compliance consulting Services
Process Validation
We have extensive experience in the validation of manufacturing processes. We can provide subject matter expertise for all upstream, downstream and fill/finish processes.
Qualification and Facility Startup
We can scale a team to support startup activities at your new facility. We have expertise in all system lifecycle requirements for facilities, utilities and equipment.
Aseptic Process Simulations
We can design and execute a program for the validation of your aseptic processes and the continued
re-qualification activities required for aseptic processing.
Environmental Monitoring Qualification
We can qualify your cleanrooms and develop an environmental monitoring program for ongoing monitoring of the classified areas in your facility.
Computerized System Validation
We can experienced computer and software validation personnel to ensure you computerized systems are designed and qualified to meet current regulatory expectations.
Data Integrity
We can provide data integrity assessment and remediation for legacy systems and well as verification of data integrity requirements for new computerized systems.
Facility Design Review
We can provide an independent and comprehensive review of the layout and design specifications for your GMP manufacturing facility.
Technology Transfer
We can provide experienced personnel with the technical knowledge and project experience to manage and execute the transfer process from start to finish.
Quality Assurance
Our Quality Assurance professionals have years of FDA industry experience supporting lot disposition, validation oversight and various quality initiatives to enhance regulatory compliance.
Remediation of Regulatory Agency Inspection Items
We have experience in supporting Consent Decree Remediation, FDA Form 483 remediation, Compliance Gap Analysis and PAI support.
Policies and Procedures
Our personnel have the technical writing skills, subject matter expertise in numerous processes and GMP disciplines, and are available to assist in the creation and enhancement of policies and procedures.
Project Management
Our experience project managers can oversee project timelines and deliverables and drive your project to completion.