There are two ways to work with us. We can take on a defined project and run it. Or one of our consultants can join your team for a contract or interim role.
Some projects need more than an extra pair of hands. They need someone to own the plan. In these engagements we agree on scope and milestones up front, then manage the work against them and report progress as we go. The team might be one consultant or several.
Typical projects include audit programs, gap assessments, inspection readiness, remediation after an FDA finding, and CSV remediation. Your people stay involved the whole way. They know your systems and they will own the results after we leave.
This works best when you have people available but nobody in-house who has run this kind of project before.
Sometimes you have the plan and the managers, and you just need more experienced people. In that case one of our consultants joins your team, reports to your managers, and follows your procedures.
A few examples: an audit specialist to run a supplier audit program. A CSV specialist for a six-month remediation. A validation PM for a system upgrade.
Before anyone starts, we have talked with them in detail about the work they have done in regulated environments. Our consultants are used to getting up to speed quickly and working without much supervision.
A pharma company is partway through an ERP upgrade and does not have enough people to keep up with IQ/OQ/PQ and change control.
A drug manufacturer has received a warning letter and committed to a remediation schedule. It needs a compliance lead and a CSV specialist to meet those dates.
A biotech is moving from clinical to commercial manufacturing. It needs a validation lead who has worked in biologics GMP production before.
A CDMO is adding clients faster than its quality system can absorb them. It needs a contract Quality Systems Manager who has run a multi-client GMP operation.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
A device maker is closing gaps against the QMSR and ISO 13485. Its procedures, design controls, and CAPA process need work. If a new ERP or eQMS is part of the plan, it needs validation help too.
Describe the problem, your systems, and any regulatory deadlines. We will tell you how we would approach it.
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