Regulatory Complexity Reduction

Quality & Regulatory: Regulatory Operations (Global Scope)

Goals & Business Drivers

Goals & Business Drivers

A global pharmaceutical company’s benchmarking study showed that their volume of regulatory submissions was ~50% greater than industry average, leading them to develop a strategy to plan and manage regulatory technical changes and reduce overall change volume.

Actions Taken

Actions Taken

An Enterey team of consultants was brought onboard to refine and implement the program strategy. They worked with the key stakeholders to develop an integrated project plan to set milestones and identify interdependencies while actively coordinating day-to-day activities for a multitude of related workstreams.

Results Achieved

Results Achieved

The team initiated and collaborated on designing a future state process and associated requirements for supporting IT solutions to reduce the time it takes to assess technical changes by over 50%. The new process standardized documentation, evaluation and prioritization of these changes in order to enable a reduction in the number of regulatory-impacting technical changes that get initiated by 20%.

PAI and Successful Filing

Quality & Regulatory: Risk Management (Global Scope)

Goals & Business Drivers

Goals & Business Drivers

A small drug-development company based in Southern California set out with the goal of acquiring a commercial product license for its oligonucleotide manufacturing facility. They instituted a pre-approval inspection (PAI) readiness program and achieved EU product approval after a successful EMA audit. The company looked to ensure the same success for their upcoming FDA inspection. The goal was to conduct a PAI to ensure a FDA inspection with no critical observations.

Actions Taken

Actions Taken

Enterey supported this PAI and inspection process through internal audits and mock inspections performed by former FDA inspectors. The Consultant team managed a gap assessment, composed a risk analysis, and partnered with the client to prioritize and address the logistics of tackling each item. The team ensured risks were successfully remediated while maintaining adherence to the applicable regulations and guidelines. Consultants designed and ran an inspection “war room” complete with a custom software program and communication process that provided necessary support and documentation to alleviate auditor requests/concerns during the inspection.

Results Achieved

Results Achieved

All FDA auditor concerns were quickly and satisfactorily resolved, resulting in a successful inspection with no critical findings. Furthermore, the client achieved their goal of receiving approval for commercial manufacture from both the EMA and FDA.

Inspection Readiness for Facility Start-up

Quality & Regulatory: Quality Systems (Regional Scope)

Goals & Business Drivers

Goals & Business Drivers

With construction and plant commissioning complete, a leading biotech manufacturer set timelines to license its new facility and to pass all required inspections – State, FDA, and EMEA Pre Approval Inspections.

Actions Taken

Actions Taken

Enterey provided a gap analysis and action plans to remediate or defend the identified gaps in the plant’s Quality System. Enterey provided project management support to the 14 departments throughout the plant and to the Director of Quality Assurance. In addition, Enterey provided the communication updates to Corporate Compliance and the GMP Core Team. Enterey also supported the staff during the inspections with defense strategies, documentation and final inspection room prep.

Results Achieved

Results Achieved

Thefacility was licensedas planned. The State, FDA and EMEAinspections were successful. There were no FDA observations. Observations issued by the State and EMEA were minor, and action plans to correct were implemented.