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Pharmaceuticals
Branded, generic and specialty pharma, supported from pre-clinical development through commercial manufacturing and post-market compliance.
The problem
One clock is development: the submission date, the study milestone, the launch window. The other is operations: batch release, deviation closure, the audit that lands whether or not the programme is on schedule. Teams built for one are routinely asked to absorb the other.
The usual failure is not incompetence, it is dilution. The quality lead handling a commercial site investigation is also reviewing submission documents. The regulatory director covering three markets is also fielding health authority questions on a fourth. Everything gets done adequately and nothing gets done well.
The practical fix is targeted capacity: the right specialist for the workstream that is squeezing everything else, brought in fast enough to matter, and released when the peak passes.
Tell us the problem. A specialist replies, not a form robot.
What we do
Study teams, monitoring and data management for programmes running across multiple sites and regions.
IND, NDA and ANDA support, lifecycle maintenance and health authority responses.
Batch record review, deviation and CAPA support, and audit readiness for commercial sites.
Case processing, aggregate reporting, signal review and risk management planning.
Validation of LIMS, MES and quality systems under 21 CFR Part 11 expectations.
Protocols, clinical study reports, regulatory documents and publication support.
2
Clocks running at once, and we staff both
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Questions
Yes, and it is the common request. The two need different people, and the mistake we most often see corrected is one team being asked to cover both.
Yes. ANDA work has its own rhythm, particularly around bioequivalence and labelling, and the specialists are not interchangeable with NDA-side people. We recruit for both.
Yes. Pre-approval inspection readiness is a defined workstream: documentation review, mock inspection, and remediation of what it finds. Start earlier than feels necessary.
For most commercial quality and regulatory roles, profiles inside 48 hours and someone working within two weeks depending on notice periods. Tell us the real start date rather than the ideal one.
Yes for roles that require it, particularly GMP quality and manufacturing support. Documentation and data-heavy workstreams are often better delivered remotely or offshore, and we will say which is which.
Related
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