Some examples of compliance/quality projects we've managed:
- Development of a Quality System, including Quality Strategy & Metrics
- Gap Analysis and Risk Assessment
- SOP Creation and Updating
- CAPA Planning and Execution
- Internal and External Audits
- Creation of Compliance Reports
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. Pharmica brings over a decade of project management experience along with a deep understanding of compliance to help your organization find balance.
Like any effective design, compliance is best when it’s noticed least. Ask us how our project managers can help your organization Get Better compliance.
"Our Pharmica consultants continue to provide that extra support that is a tremendous help to the team. They are doing an excellent job and it is much appreciated."
Vice President, Clinical Safety & Pharmacovigilance