In the biopharmaceutical and biotechnology industries, compliance with Current Good Manufacturing Practices (cGMP) is non-negotiable. At OAAK Biosolutions, we offer expert GMP consulting services designed to help pharmaceutical companies, cell and gene therapy developers, and biopharma manufacturers maintain regulatory readiness, streamline Quality Assurance (QA), and eliminate manufacturing risks.
From initial facility commissioning to full-scale FDA inspection readiness, our tailored consulting approach ensures your operations meet strict global standards set by the FDA, EMA, and WHO.
Our cGMP consulting solutions cover the complete life cycle of pharmaceutical quality management and regulatory compliance.
Facing an FDA or EMA inspection requires meticulous preparation and complete documentation transparency.
Mock FDA Audits: Simulating actual regulatory inspections to identify compliance gaps before official audits.
Form 483 & Warning Letter Remediation: Expert technical support to draft swift, comprehensive responses and CAPA plans.
Pre-Approval Inspection (PAI) Prep: Ensuring your facility, technical documentation, and personnel are 100% ready for PAI audits.
A robust Quality Management System (QMS) is the backbone of compliant manufacturing operations.
QMS Design & Optimization: Implementing standard operating procedures (SOPs), document control systems, and change management workflows.
Deviation Management & CAPA: Conducting rigorous root cause analysis for manufacturing deviations to prevent recurrence.
Risk Management (ICH Q9): Embedding Quality Risk Management (QRM) framework into daily operations.
Scaling up manufacturing or upgrading facilities requires complete process qualification and Equipment Validation.
Commissioning & Qualification (C&Q): Comprehensive IQ, OQ, and PQ execution for manufacturing equipment and critical utilities (HVAC, Water for Injection).
Cleaning & Process Validation: Ensuring cross-contamination controls and validation protocols meet cGMP standards.
Technology Transfer Oversight: Safe, seamless transfer of analytical methods and manufacturing processes to CDMOs.
Maintaining control over your third-party supply chain is a key FDA and cGMP requirement.
Third-Party Vendor Audits: Assessing raw material suppliers, testing laboratories, and CMO/CDMO facilities.
Quality Agreements: Drafting clear, compliant Quality Agreements specifying responsibility matrixes.
Gap Analysis & Audit: Detailed assessment of your facility, SOPs, batch records, and QMS against current cGMP expectations.
Remediation Action Plan: Designing a prioritized roadmap with realistic timelines, resource allocation, and CAPA strategies.
Implementation & Training: On-site and remote execution of QMS upgrades, qualification protocols, and staff cGMP training.
Final Inspection Readiness: Final mock audits and walkthroughs to confirm full compliance ahead of regulatory visits.
Deploy rigorous cGMP audit protocols and remediation frameworks designed to align strictly with global regulatory expectations, including FDA, EMA, and ICH Q10 standards.
Seamlessly connect technical operations with robust Quality Management Systems (eQMS), ensuring regulatory compliance and data integrity without compromising manufacturing throughput.
Receive customized compliance strategies engineered specifically for small molecules, biologics, vaccines, and advanced therapeutic modalities (Cell & Gene Therapy).
Identify and eliminate contamination vulnerabilities, SOP deviations, and operational bottlenecks early through formal Quality Risk Management (QRM) and CAPA frameworks.
GMP stands for Good Manufacturing Practices, while cGMP stands for Current Good Manufacturing Practices. The “c” highlights the legal requirement for biopharmaceutical companies to use up-to-date technologies and modern quality frameworks rather than outdated systems.
We conduct an immediate impact assessment, perform thorough root-cause analysis for cited deviations, draft objective Corrective and Preventive Action (CAPA) plans, and assist leadership in presenting a strong response to the FDA within required deadlines.
Yes. We perform comprehensive third-party cGMP audits of CDMOs, testing labs, and raw material suppliers to ensure your partners adhere to required quality standards and contractual Quality Agreements.
Avoid costly regulatory delays, batch rejections, and audit citations. Partner with OAAK Biosolutions for expert cGMP consulting and quality assurance solutions.