Compliance & Quality

regulatory strategies

•Develop Quality System, including Quality Strategy and Metrics

•Conduct Gap Analysis and Risk Assessment

•Conduct CAPA planning and execution

•Conduct internal and external audits

•Create informative reports summarizing data

Compliance and Quality are synonymous with clinical execution. Much like Goldilocks, many organizations struggle with calibrating the resources they’re applying to get their compliance programs “just right.” Not enough rigor and attention, and your organization will ultimately be cited by health authorities, potentially crippling your ability to progress development of your assets. Too much rigor, and your organization is paralyzed by pointless bureaucracy, exacerbating your development costs and encumbering timelines.

New technologies and approaches offer the promise of efficiency, but can they be implemented without adding additional risk? Pharmica brings its ten years of experience in the ever accelerating understanding of compliance to help your organization find balance.

For Biotechs who are dealing with the shock of needing to scale their organization to prepare for more and larger scale studies, Pharmica’s Quality consultants can provide an assessment of where gaps need to be filled, and how to sustain compliant clinical operations.

For larger Pharmaceutical clients, Pharmica can streamline compliance SOPs without risking health authority citations.

Like any effective design, compliance is best when its noticed least and puts professional in direct contact with their work. Ask us how we can help your organization Get Better.

“Your expertise along with your honesty and integrity set Pharmica Consulting apart from any other consulting company. I can always rely on your honest approach.”
-Chief Operating Officer