Pal Management Consulting LLC is a consulting firm providing quality and regulatory assistance and cost-effective solutions to the companies in the FDA regulated industries with specific focus on:

Pharmaceuticals
Medical Devices
Dietary Supplements
Biopharmaceuticals
Our services include:

Quality Systems Remediation: The implementation of a remediation plan for Quality Management System (QMS) to ensure the compliance to regulatory requirements. Also, to ensure that implemented remedial actions are comprehensive, compliant, and sustainable. Provided on-site support for warning letter remediation and 483 Observations for various clients to; from execution of remediation protocol to steady-state of the remediated quality systems.

Regulatory Compliance: Implementing the systems and practices to comply with the regulatory regulations, guidance, and industry best practices.

Validation: The validation of the processes, and cleaning procedures to confirm that the products manufactured are meeting the predetermined specifications.
     Preparation and Execution of Process Validation Protocols and Reports
     Preparation and Execution of Cleaning Validation Protocols and Reports
     Preparation and Execution of Process Characterization Protocols and Reports
     Preparation and Execution of Stability / Exhibit batches Protocols and Reports

Third Party Auditing: In this program, we evaluate the existing quality systems documents and practices to ensure compliance to the regulations and guidance. We also, help our clients to resolve the issues identified during audits, as applicable.

Quality Systems Gap Assessments: Identifying the gaps in the quality systems, procedure, and practices by performing the documents and physical verification of the practices.

Corrective and Preventive Actions Plans (CAPA): Development and implementation of the robust CAPA System which enables to identify the appropriate actions to prevent recurrence and occurrence of the potential nonconformance.

Continuous Improvement: After assessing the customer’s objective and requirements, we deliver short-term value and long-term sustainability to continue successful process improvement on its own.

Failure Investigations and Problem Solving: The investigation for the nonconformance by utilizing various investigations tools and identifying the root cause or most probable cause. After the cause(s) are identified, the appropriate actions are implemented to resolve the problem.

Change Management: To design and implement effective change management procedures and practices to confirm that all the changes are reviewed, evaluated, assessed and approved prior to implementation of the change. Technical Writing: Authoring procedures, work instructions, protocols, reports, investigations, and other documents associated with the quality systems.

Supplier Quality Management: To develop the comprehensive, compliant, and sustainable Supplier Quality Management System using risk-based approach that ensures the robust purchasing controls and supply chain system.