Frequently Asked Questions

Good Manufacturing Practice (GMP) is a system of processes and procedures that ensures pharmaceutical products are consistently produced and controlled according to quality standards. It's crucial for ensuring product safety, efficacy, and compliance with regulatory requirements. GMP covers all aspects of production from raw materials to finished products, including personnel, facilities, equipment, documentation, and quality control.

We typically begin engagements within 1-2 weeks of contract signing, depending on project scope and resource availability. For urgent matters such as regulatory inspections or critical compliance issues, we can often mobilize within 48-72 hours. Our team works efficiently to understand your needs, develop a project plan, and begin implementation as quickly as possible.

Project timelines vary based on scope and complexity. Most consulting engagements range from 4-12 weeks, while comprehensive system implementations may take 3-6 months. Audits typically take 1-2 weeks on-site plus 1-2 weeks for report delivery. We provide detailed project timelines during the initial consultation and keep you updated throughout the engagement.

Yes, we work with companies of all sizes, from startups to large multinational corporations. We understand that smaller companies have different needs and budgets, so we tailor our approach accordingly. Our flexible engagement models and scalable solutions ensure that companies at any stage can access high-quality GMP consulting services.

We have a global presence and serve clients across the Middle East, Asia, Europe, Africa, and the Americas. Our team has deep understanding of both international standards (FDA, EMA, WHO) and local regulatory requirements, enabling us to provide comprehensive support regardless of your location.

We perform various types of audits including pre-inspection audits, gap analysis assessments, supplier/vendor audits, internal quality system audits, and mock regulatory inspections. Each audit is tailored to your specific needs and regulatory requirements, providing comprehensive evaluation and actionable recommendations.

Absolutely. Our inspection readiness services include comprehensive preparation workshops, mock inspections, documentation review, staff training, and on-site support during actual inspections. We help you identify and address potential issues before inspectors arrive, ensuring you're fully prepared and confident.

Yes, we offer ongoing support and maintenance services to help you maintain compliance and continuously improve your systems. This can include periodic audits, training updates, regulatory monitoring, and consultation on new challenges as they arise. We build long-term partnerships with our clients.

Our team consists of certified quality professionals, former regulators, and industry veterans with extensive experience in pharmaceutical manufacturing, regulatory affairs, and quality systems. Many hold advanced degrees and professional certifications in GMP, quality management, and regulatory compliance.

We work with major global regulatory standards including FDA (US), EMA (Europe), WHO-GMP, ICH guidelines, and various national regulatory requirements. Our expertise covers cGMP, GLP, GCP, and other Good Practice guidelines applicable to pharmaceutical operations worldwide.

Confidentiality is fundamental to our practice. We sign comprehensive non-disclosure agreements before any engagement and maintain strict confidentiality protocols throughout our work. Our team is trained in data protection and information security, ensuring your proprietary information and trade secrets are fully protected.

Yes, we specialize in remediation services following regulatory inspections. We help you understand findings, develop comprehensive remediation plans, implement corrective actions, and prepare responses to regulatory authorities. Our goal is to resolve issues effectively and prevent recurrence.

We use a risk-based approach that prioritizes critical areas with the highest impact on product quality and patient safety. This allows for efficient resource allocation, focusing efforts where they matter most. We conduct risk assessments, develop risk mitigation strategies, and continuously monitor and adjust based on changing conditions.

Our engagement process typically begins with an initial consultation to understand your needs and challenges. We then conduct a preliminary assessment, develop a customized proposal, and upon agreement, execute the project with regular communication and progress updates. We conclude with comprehensive reporting and recommendations, followed by optional ongoing support.

Yes, we offer comprehensive GMP training programs tailored to different roles and responsibilities. Our training covers topics such as GMP fundamentals, documentation practices, quality systems, regulatory requirements, and inspection readiness. Training can be delivered on-site, virtually, or through our online learning platform.

We recognize that every company has unique operations, challenges, and goals. Our approach involves deep understanding of your specific context—your products, processes, markets, and organizational culture. We then develop tailored solutions that align with your business objectives while ensuring regulatory compliance and operational efficiency.

Deliverables vary by engagement type but typically include comprehensive reports with findings and recommendations, documentation (SOPs, protocols, procedures), implementation plans, training materials, and ongoing support documentation. All deliverables are provided in formats that are practical, implementable, and aligned with regulatory expectations.