Services

Embark on a journey with Pharmacleus, where we merge expertise with what’s pragmatic and compliant to deliver exceptional pharmaceutical consulting services. Our commitment to quality and compliance is the foundation of our tailored solutions, designed to meet the dynamic needs of the pharmaceutical industry. Explore our range of specialized services below, each crafted to ensure your operations excel in efficiency, compliance, and quality.

➢ Supplier Audits

Vendor audits are crucial in the pharmaceutical industry for maintaining a high-quality supply chain. Our vendor audits focus on:

QMS Effectiveness: Evaluating the vendors’ Quality Management System to meet the requirements of the services they provide for your company.
Risk Assessments: Analyzing potential risks associated with each vendor and their impact on your supply chain.

➢ Remote Batch Record Review Services

Our remote batch record review services offer a flexible and efficient way to ensure the accuracy and compliance of your batch records without the need for on-site visits. This service includes:

Comprehensive Review: Detailed examination of batch records to ensure they meet regulatory requirements and internal quality standards to support batch release.

➢ QA Person-in-Plant (PIP) Services

Our QA Person-in-Plant (PIP) services are designed to bridge the gap between your operational needs and regulatory requirements, ensuring your products are manufactured to the highest standards. Our service offerings include:

Onsite Quality Oversight: Direct quality support and guidance on the manufacturing floor. Each PIP is a seasoned professional with extensive knowledge in pharmaceutical manufacturing. They bring their expertise directly to your plant floor, offering immediate support and guidance to uphold the stringent quality standards expected in the industry.
Compliance Assurance: With ever-evolving regulations in the pharmaceutical industry, our PIPs ensure your processes remain compliant with all relevant standards and guidelines, mitigating risks and safeguarding your reputation.
Real-Time Process Monitoring: Our PIPs are on the floor, providing continuous oversight and monitoring of the manufacturing processes. They are trained to identify and address potential quality issues before they escalate, ensuring uninterrupted production flow.
Continuous Improvement: Our PIPs don’t just maintain quality; they help elevate it. Through ongoing assessments and feedback, they aid in refining processes, ensuring continuous improvement in your manufacturing operations.

➢ General Pharma Consulting

Our tailored consulting services helps firms address a range of needs from regulatory compliance to process optimization, ensuring that their business stays at the forefront of the industry. Our general pharma consulting service includes:

Quality Remediation: Pharmacleus offers a comprehensive Quality Remediation service, focusing on identifying, analyzing, and resolving quality issues through a tailored plan, ensuring effective implementation and continuous quality maintenance.
Quality Advising: Our Quality Advising service provides strategic guidance in quality management, encompassing system assessment, integration of best practices, and ongoing support to elevate and sustain your quality standards.
Responding to Regulatory Findings: Our team of consultants will assist you in analyzing regulatory feedback, developing structured responses, implementing corrective action plans, and ensuring continuous compliance with regulatory standards.
QMS startup: Our QMS Startup service is dedicated to designing and implementing a robust Quality Management System (QMS) tailored to your specific needs, ensuring it aligns with industry regulations and enhances your operational efficiency.

Why Choose Pharmacleus?

Expertise: Our team comprises industry veterans with over 50+ years years of experience in pharmaceutical quality and compliance.
Customization: We understand that each company is unique. Our services are tailored to meet your specific needs.
Compliance Focused: With a deep understanding of regulatory requirements, we ensure that your operations remain compliant.

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Let Pharmacleus be your partner in navigating the complexities of the pharmaceutical industry. Contact us today to learn more about how we can assist you in achieving operational excellence.