Case Studies
Computer System Validation for a Global Pharma Manufacturer
Client: Mid-size pharmaceutical manufacturer operating across three countries
Challenge: The client was preparing for an FDA pre-approval inspection and had identified critical gaps in the validation documentation for their Laboratory Information Management System (LIMS) and electronic Quality Management System (eQMS). Both systems had been in use for over four years with no formal validation lifecycle in place.
Clinical Trial Recruitment for a Phase III Oncology Study
Client: US-based biotech company conducting a multi-site Phase III oncology trial
Challenge: The sponsor was running 14 months behind on patient enrollment across 22 clinical sites in the United States and Europe. Eligibility criteria were narrow, site coordinators were under-resourced, and the existing recruitment strategy relied solely on physician referrals. The delay was threatening the regulatory submission timeline and increasing per-patient costs significantly.
QMS Implementation for a Biotech Startup Preparing for First IND Submission
Client: Early-stage biotech startup developing a novel biologics therapy
Challenge: The company had strong science but no formal Quality Management System in place. With their first Investigational New Drug (IND) application approaching, they needed a compliant, scalable QMS built from the ground up — including SOPs, deviation management, CAPA processes, and training records — within a tight four-month window.
FDA Inspection Readiness for a Medical Device Manufacturer
Client: Medical device manufacturer preparing for an unannounced FDA Quality System inspection
Challenge: The company had received a Form 483 with six observations following a previous FDA inspection two years earlier. While corrective actions had been implemented, the internal team lacked confidence that the CAPA responses had been fully embedded into daily operations. Key concerns included incomplete device history records, inconsistent complaint handling procedures, and gaps in supplier qualification documentation.
CDMO Selection and Qualification for a Rare Disease Drug Program
Client: Specialty pharma company developing an orphan drug for a rare metabolic condition
Challenge: The company needed to identify and qualify a Contract Development and Manufacturing Organisation (CDMO) capable of handling a highly complex biological manufacturing process under tight GMP standards. Previous vendor shortlisting had stalled due to unclear evaluation criteria, inconsistent audit findings across three candidate CDMOs, and disagreements between the technical and regulatory teams on risk thresholds.
