Hire Pharma Knowledge Consulting, a pharma consultant specializing in Clinical Studies and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: Saudi Arabia
Willing to work in: Global
Consultant Type: Consulting Firm
Expertise summary: PharmaKnowl Consulting is an SFDA-licensed regulatory consulting firm established in Riyadh, Saudi Arabia, with expertise across pharmaceutical, biotechnology, and medical technology sectors. The firm provides regulatory strategy, product registration, dossier and technical file development, regulatory submissions, clinical research support, and pharmaceutical quality and GMP consulting. Its services also include regulatory due diligence, gap analysis, life-cycle management, manufacturer GMP and ISO auditing, and support for technology transfer and licensing projects. PharmaKnowl's team combines regulatory authority and industry experience, including former SFDA professionals, to support companies navigating Saudi regulatory requirements and market access. The firm is also licensed by the SFDA for regulatory consulting, pharmacovigilance, authorized representation, and clinical research organization activities. - Show More
PharmaKnowl Consulting provides clinical research and development support through its SFDA-licensed CRO capabilities. The firm supports clinical project management, trial data management, regulatory submissions to ethics committees and competent authorities, functional service provision, statistical analysis, and preparation of clinical documentation. These capabilities allow pharmaceutical, biotechnology, and MedTech companies to receive coordinated support throughout clinical development activities.
PharmaKnowl Consulting provides GMP auditing services for pharmaceutical manufacturers as part of its Quality and GMP consulting activities. The firm offers experienced auditors, including professionals with former SFDA inspection experience, to assess manufacturing operations, quality systems, documentation, and compliance practices. Its audits can help organizations identify regulatory gaps, strengthen inspection preparedness, and improve overall compliance with applicable GMP requirements.
PharmaKnowl Consulting supports pharmaceutical organizations in evaluating and strengthening GMP compliance. Its team assists companies with identifying compliance gaps, reviewing existing quality systems, evaluating manufacturing practices, and developing practical measures to address regulatory requirements. The firm\'s combination of industry and regulatory authority experience enables it to provide focused support for maintaining effective GMP systems and improving overall regulatory preparedness.
PharmaKnowl Consulting supports clinical research projects with trial design and related study-planning activities. Drawing on its clinical research and CRO capabilities, the firm can assist organizations in structuring clinical studies, coordinating regulatory requirements, developing appropriate study documentation, and aligning trial activities with applicable regulatory expectations and project objectives.
PharmaKnowl Consulting supports the development, assessment, and improvement of pharmaceutical quality management systems. The firm has experience developing quality systems aligned with GMP and ISO standards and can assist organizations with gap assessments, quality-system review, documentation, compliance improvement, and preparation for regulatory or certification audits.
PharmaKnowl Consulting supports pharmaceutical and life-sciences companies with regulatory filing activities, including product registration, dossier and technical file development, regulatory submissions, life-cycle management, and responses to regulatory authority inquiries. The firm\'s experience with SFDA requirements enables it to assist companies in preparing compliant submission packages, performing regulatory gap assessments, coordinating documentation, and supporting applications through review and approval processes.
