Strategic Consulting for Compliance
& Quality Assurance

Ensuring quality and regulatory compliance isn’t all about audits; sometimes you just need some advice. Maybe you're new to pharma research or manufacturing and need help determining what to focus on first. Or maybe you're an industry veteran looking for feedback on a Part 11 gap analysis or computer systems risk assessment. And maybe you need something in between.

Our team can act as an extension of your own by providing the strategic consulting and technical advice you need. Here are some of the ways we’ve been able to help our clients.

GCP / GLP/ CGMP

GxP Consulting

Performing gap analyses against regulations
Serving as advisors for Project Managers and QA Managers
Training staff in regulatory requirements and research techniques
Conducting process flow assessments for CGMPs
Developing clinical trial materials labeling
Conducting due diligence of manufacturing operations and processing systems
Serving as liaison among contractors (API manufacturers, laboratories, manufacturing, and distribution centers)
Providing a “man in the plant” for manufacturing support
Assisting start-up companies with ramp-up activities related to manufacturing and quality assurance, including development of internal staff and/or outsourcing
Developing regulatory strategies and strategic plans for interactions with the FDA
Writing CMC portions of INDs and NDAs
Assisting personnel at new clinical sites in establishing efficient operations

Computer Systems

Computer Systems Consulting

Orient companies new to the regulated industry about validation, Part 11, and data integrity obligations
Mentor your staff on how to take computer system projects and processes forward
Conduct gap analyses of your systems against regulatory requirements (e.g., Part 11), and advise you on what to address first
Serve as a “sounding board” for adhoc compliance questions within your organization
Develop practical, customized, and appropriate approaches to your computer system validation (CSV) efforts and documentation
Review/revise your vendor qualification SOPs
Bridge the gap between IT, business units, QA, and vendors by addressing expectations and responsibilities
Coach your staff on CSV concepts and Part 11 regulations as you execute your own validation project
Assess risks to data integrity as your data flow through your systems
Write validation plans and summary reports for your systems
Identify system relevance, system and vendor risk, and interpret audit findings
Provide validation document templates to make your processes efficient and repeatable
Work with your business units to define and document requirements for new computer systems

Do you need something you don’t see listed above? Give us a call.

Strategic Consulting

Strategic Consulting for Compliance & Quality Assurance

GCP / GLP/ CGMP

Computer Systems

Strategic Consulting for Compliance
& Quality Assurance