Compliance Group

Compliance Group's motto is to provide "right-sized" compliance solutions by balancing risks vs benefits. Compliance Group is run by a team who are at the cutting edge of developments in Compliance. The team is supporting mid-size and large Life Sciences clients and is actively engaged in discussions with FDA consortiums that set the direction for the Industry. Engaging us will not only ensure your timelines are met but will also result in contributions from our organizational assets - i.e. working knowledge and solutions based on the latest Compliance trends from FDA consortiums. Whether you are in need for a little guidance or looking for outsourced delivery models, Compliance Group can customize the solution and delivery model for you. We have proven expertise supporting customers with the following: Setting up QMS and SQA policies - We can help you get your policies, procedures, and validation templates in place in an expedited manner. Audit Readiness Assessments - If there is an impending Internal Audit or External Regulatory Agency Inspection, we can perform Audit Readiness Assessment to assess the health of your systems' compliance to show you where you're compliant and where you're not. We will also deliver a prioritized action plan and help execute the remediation plans so you can be ready on time. Validation Execution - If you have a project or a system that requires validation, we can deliver it for you using our risk based 'Right-sized' compliance approaches that focus on doing what is right for you. Supplier Quality Audits - If you need help in auditing your software/equipment vendors, our expert consultants can step in to perform the audit on your behalf. Remediation Packages - We perform Gap Assessments to assess your company's systems for compliance with 21 CFR Part 11 or Annex 11 and deliver remediation plans along with expedited Onsite/Offshore delivery models. Process Improvement Packages - We can assess your QMS and SQA practices and identify and implement improvements that can save significant time and budget. Please visit our "Services Offered" page for a detailed service catalog of our services. Compliance Group