Hire PharmQA Compliance Services, a pharma consultant specializing in Analytical Testing, Clinical Studies, FDA Inspections, Pharmaceutical Manufacturing and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Consulting Firm
Expertise summary: PharmQA Compliance Services is a pharmaceutical consulting firm specializing in quality assurance, quality control, and regulatory compliance. The firm supports API and formulation manufacturers, testing laboratories, and clinical research organizations through GMP audits, FDA inspection readiness, warning letter remediation, quality management systems, and GMP training. Its capabilities also include Good Clinical Practice audits, cleaning validation, analytical method validation, and regulatory filing support. Through compliance assessments, documentation support, training, and corrective action planning, PharmQA helps clients address quality gaps and prepare their facilities, systems, and teams for regulatory inspections. - Show More
PharmQA supports cleaning validation through protocol development, documentation review, and assessment of cleaning procedures and validation evidence. Its experience includes applying health-based exposure limits, including permitted and acceptable daily exposure values, when reviewing residue limits. The firm helps manufacturers evaluate their cleaning validation approach, address documentation gaps, and strengthen controls intended to reduce cross-contamination risks.
PharmQA supports FDA inspection readiness through facility assessments, documentation reviews, and preparation of site personnel. Its services include mock inspections, pre-approval inspection assessments, interview preparation, and guidance on inspection hosting and document management. The firm also compares regulatory submission information with supporting site records to help clients identify inconsistencies and address gaps before inspection.
PharmQA assists pharmaceutical organizations with FDA warning letter remediation through compliance assessments, response preparation, and corrective action planning. Its documented experience includes warning letter remediation assignments and support with regulatory correspondence. The firm helps clients review the deficiencies raised, strengthen affected procedures and quality systems, and monitor corrective actions through verification activities and effectiveness checks.
PharmQA conducts GMP audits and gap assessments for API and formulation manufacturers, contract facilities, laboratories, and suppliers. Its assessments cover facilities, equipment, manufacturing practices, quality systems, documentation, and data integrity. The firm also reviews validation activities and corrective action programs, helping clients identify compliance gaps and prioritize improvements across internal operations and external partners.
PharmQA delivers customized GMP training for pharmaceutical manufacturing, laboratory, and quality teams. Programs cover documentation practices, data integrity, investigation methods, root cause analysis, CAPA, quality risk management, and inspection preparation. The firm develops training modules around client requirements and site procedures, helping employees understand compliance expectations and apply them to their everyday responsibilities.
PharmQA provides GCP auditing and compliance support for clinical research organizations, investigator sites, and bioequivalence studies. Its capabilities include study and quality system audits, trial master file reviews, clinical laboratory assessments, and review of study documentation. The firm also supports GCP SOP development and training, helping clients identify gaps in study conduct, documentation, and quality oversight.
PharmQA supports analytical method validation, verification, and transfer through the preparation and review of protocols, reports, and supporting laboratory records. Its capabilities include assessments of analytical and microbiological method validation, along with review of associated instrument qualification documentation. The firm helps laboratories assess whether validation evidence supports the intended use of their methods and identify areas requiring further work.
PharmQA supports the development and improvement of pharmaceutical quality management systems through quality manuals, SOPs, forms, and supporting documentation. Its work covers deviations, change control, investigations, complaints, recalls, CAPA, and quality risk management. The firm also assesses existing systems and data integrity controls, helping organizations establish clearer responsibilities, consistent procedures, and documented quality oversight.
PharmQA supports pharmaceutical regulatory submissions through preparation and review of ANDA and DMF documentation and responses to regulatory deficiencies. Its services include reviewing manufacturing, quality, and analytical information against underlying records and supporting reports. The firm helps clients improve consistency across submission documents and address gaps in the evidence supporting regulatory applications.
