SERVICES

We provide expert consulting services in:

Quality Strategy

Project Management:

It is rare that complex Quality projects have PMs that possess the technical skills and experience to both facilitate hitting the agreed upon milestones while also making the decisions necessary to ensure Quality and compliance requirements are met. We do.

M&A Evaluation:

Quality is an often-overlooked area of potential M&A targets. We can help ensure that the full Quality and Compliance history and current status of the firm is well understood.

Organizational Design – An efficient, high-performing organization does not happen by accident. It starts by designing and implementing the right structure to ensure R&Rs are clear, customer needs are met, and that the tasks are assigned in an efficient, compliant manner.

Phase Appropriate cGMPs:

A scalable QMS is a well-designed QMS where risk management and compliance are foundational.

Risk Management:

A mature QMS is one where risks are proactively managed by determining the RPN, and taking appropriate action based on the rankings.

Compliance and QMS

Data Integrity:

All of a firm’s processes and documentation must rely on sound data integrity processes. Data integrity is as important as the drug or device that the company produces, because, without it, that device or drug is considered adulterated.

Quality System Development:

Designing and implementing a robust Quality System sets the stage for an efficient, effective, and compliant organization.

Business Process Harmonization:

Whether a firm is bringing on a new site, merging with another company or needing to simplify a bloated QMS, we can help.

Quality Operations and Batch Disposition:

Designing batch records that are easy to follow and execute, implementing a shop floor QA team that effectively partners with operations, and a batch disposition process that ensures that the right elements are subject to Quality review and release is key to meeting customer expectations and business needs.

Health Authority Inspections

Readiness Planning:

Whether you are preparing for your first inspection or implementing a program to ensure a constant state of readiness, we can assist.

Inspection Management – Developing a set of tools, a cohesive inspection team, and clear roles and responsibilities is key to efficiently fielding requests with high quality

Training:

Inspections require a significant amount of training. All staff require behavioral instruction, SMEs require training and rehearsals, and the inspection team itself needs training and mocks to ensure that everyone is working in a cohesive manner

Response Writing:

If the firm receives observations, a thorough, system based response is expected.

Remediation - All commitments must be well defined, planned, and implemented on time. We can also assist with Health Authority follow ups.