Our Services
XFDA Pharma Advisors — Regulatory & Compliance Capabilities
Success in today’s fast-moving biopharmaceutical environment requires proactive regulatory strategy and continuous inspection readiness. XFDA Pharma Advisors delivers end-to-end regulatory consulting — backed by decades of FDA and industry expertise — supporting clients from early development through submission, approval, and post-market compliance.
We support organizations worldwide with a full spectrum of services, including:
- CGMP Audits and FDA/EMA inspection readiness
- Responses to FDA Form 483 and Warning Letters
- Independent 3rd party assessment and oversight
- Addressing CRLs
- CGMP compliance
- Inspection readiness activities
- SMEs coaching, backroom and front room management
- QMS development and implementation
- Product and process validation
- Internal and corporate auditing management and execution
- Cultural and organizational change initiatives
- Data integrity assessment and remediation
- Root cause analysis and critical thinking
- Supplier controls and CMO management (including inspection readiness)
- Comprehensive ANDA, NDA and CMC review
- Mock PAI and surveillance inspections
- 6 system comprehensive baseline assessment
- Manufacturing and laboratory oversight
- Comprehensive remediation plans
- Training and personnel development
- And More…..
Strategic Regulatory Support
We help sponsors and manufacturers develop practical, business-aligned regulatory strategies that support successful approvals and market continuity.
- Regulatory strategies tailored to your product and lifecycle stage, ensuring the right priorities at the right time.
- CMC section preparation and gap analysis for IND/NDA/ANDA/BLA submissions.
- Dossier development and support for regulatory meetings and agency communications.
- Cross-discipline review of comparability, analytical data, microbiology, and sterility assurance.
Facility Compliance & Inspection Readiness
Non-compliance with CGMP can delay approvals and create major business risks. We help prevent and resolve these issues with proactive compliance solutions.
- In-situ mock inspections and full pre-approval inspection simulations to ensure readiness and confidence.
- On-site, remote, and post-audit support to strengthen outcomes and ensure sustained compliance.
- Practical, role-based training for leadership and operations teams — building real-world preparedness and strong inspection readiness.
- Targeted remediation, FDA 483/Warning Letter responses, and risk-based compliance improvements.
- Flexible support for pre-, during-, and post-inspection needs.
Expert guidance rooted in global regulatory standards, with strong experience in API and sterile product manufacturing compliance.
Compliance Auditing & Oversight
We conduct comprehensive GxP audits to support compliance across global markets:
- Mock PAI and pre-approval audits to ensure FDA-ready operations.
- For-cause and independent investigations to close compliance gaps and reinforce GMP control.
- Due diligence and vendor audits to ensure compliant and reliable GMP partners.
- Routine readiness audits to maintain compliance and prepare for regulatory inspections.
- CMO audits and lab oversight to ensure strong GMP compliance across partners.
Coverage includes sterile products, biologics, oral solids, transdermals, liquids/creams, APIs, excipients, and dietary supplements — ensuring compliance across diverse manufacturing platforms.
Remediation & Risk Correction
Remediation is resource-intensive and demands disciplined execution. We lead and manage corrective actions to ensure sustainable GMP compliance and long-term operational improvement.
- FDA 483 and Warning Letter response support — ensuring clear, compliant remediation.
- Independent reviews of records and data to detect gaps and improve GMP compliance.
- Interpreting FDA action levels (OAI, VAI) and defining targeted, effective response strategies.
- Independent manufacturing and lab oversight, including GMP-aligned product release support.
- CAPA development, tracking, and effectiveness checks to ensure lasting compliance.
- Preparation and support for regulatory meetings to ensure clear communication and aligned compliance strategies.
Quality Management Systems (QMS)
From new QMS setups to enterprise-wide enhancements, we design and implement systems that strengthen compliance and drive continuous improvement.
- QMS design and implementation for new or expanding product areas — ensuring scalable compliance.
- Validation and qualification protocols (DQ/IQ/OQ/PQ) for compliant equipment, processes, and software.
- Process and computer software validation support to maintain reliable, GMP-aligned operations.
- ANDA/NDA compliance reviews and system enhancements based on internal assessments and third-party audit findings.
Education & Training
We deliver interactive, customizable training — on-site or virtual — to strengthen organizational capability and support sustained GMP compliance.
- CGMP fundamentals and advanced training to strengthen compliance awareness and operational excellence.
- Data integrity training focused on assessments, remediation, and maintaining secure, compliant records.
- OOS/OOT investigations and root-cause analysis training to improve decision-making and investigation quality.
- Nitrosamine risk assessment
- Contamination control and aseptic technique training to reinforce sterile operations and prevent quality risks.
- Internal auditor development and certification training to build strong GMP audit capability.
- FDA inspection preparedness training to build confidence and ensure smooth inspections.
- CAPA, investigation, and nonconformance management training to strengthen corrective actions and compliance control.
Value & Benefits
- Reputation: Strong inspection readiness and successful mock audits demonstrate commitment to quality and build stakeholder confidence.
- Cost avoidance: Proactive readiness helps prevent costly compliance issues, rework, and recalls.
- Practical outcomes: We turn regulatory expectations into sustainable systems and practices that protect product quality and business continuity.
Let’s Begin Your Compliance Journey
Whether you’re preparing for an FDA submission or strengthening your quality systems, our experts are ready to help. Connect with us today for tailored, GMP-aligned consulting that delivers confident compliance and real results.