Regulatory compliance is fundamental to ensuring the safety, identity, efficacy / strength, and quality of biopharmaceutical products. Our GxP Auditing service provides a comprehensive assessment of your operations to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), and Good Pharmacovigilance Practices (GPvP).
We conduct in-depth facility audits, documentation reviews, quality systems, personnel interviews, personnel training,investigations, and data integrity assessments to identify compliance gaps and areas for improvement. Our team specializes in aligning your operations with USFDA, EMA, MHRA, PMDA, TGA and other global regulatory bodies, helping to mitigate risks before formal inspections.
With a proactive auditing approach, we help companies improve batch consistency, data integrity, and regulatory readiness, ensuring that your biopharmaceutical products meet the necessary industry standards.
Regulatory inspections can be complex, demanding, and challenging but preparation is key to avoiding compliance issues. Our Inspection Readiness service is designed to help biopharmaceutical companies confidently face audits from USFDA, EMA, MHRA, and other health authorities.
We provide:
By strengthening your quality systems, manufacturing processes, and clinical documentation, we help ensure that your company is well-prepared for any regulatory inspection. Our team also provides real-time support during inspections to guide interactions with regulatory auditors.
Our Mock Inspections simulate real regulatory audits, allowing biopharmaceutical companies to assess their compliance posture before an official inspection. These inspections identify potential compliance risks, operational inefficiencies, delay of document retrievals for submission and review, unfriendly inspection atmostphere / setups, and documentation gaps that could lead to regulatory citations.
During our mock inspections, we evaluate:
Following the inspection, we provide a detailed report with findings, risk levels, and corrective action recommendations, ensuring that your company can address any issues proactively and maintain compliance with global regulatory expectations.
In the biopharmaceutical industry, Quality Assurance (QA) is essential and critical for ensuring product safety, efficacy / strength, and regulatory compliance. Our QA services focus on developing, implementing, and optimizing Quality Management Systems (QMS) to meet GMP, GLP, GDP, GPvP, and GCP standards.
We assist with:
Quality Control (QC) is a critical component of biopharmaceutical manufacturing, ensuring the identity, purity, potency, and consistency of drug products. Our QC services provide analytical method validation, stability studies, microbiological testing, and compliance assessments to meet industry regulations.
Our key QC services include:
By implementing state-of-the-art effective QC procedures, we help biopharmaceutical companies ensure regulatory compliance, improve batch reliability, reproducibility, and reduce manufacturing deviations.
The biopharmaceutical industry requires highly specialized talent to drive innovation, compliance, and operational success. Our Recruiting & Staffing service helps companies find top-tier professionals in quality assurance, quality control, regulatory compliance, manufacturing, and research & development (R&D).
We specialize in sourcing candidates for roles such as:
With access to a network of highly skilled professionals, we provide permanent, contract, and project-based staffing solutions to help biopharmaceutical companies build strong teams that drive compliance, efficiency, and innovation.
Regulatory compliance is fundamental to ensuring the safety, identity, efficacy / strength, and quality of biopharmaceutical products. Our GxP Auditing service provides a comprehensive assessment of your operations to ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Distribution Practice (GDP), and Good Pharmacovigilance Practices (GPvP).
We conduct in-depth facility audits, documentation reviews, quality systems, personnel interviews, personnel training. Investigations, and data integrity assessments to identify compliance gaps and areas for improvement. Our team specializes in aligning your operations with USFDA, EMA, MHRA, PDMA, and other global regulatory bodies, helping to mitigate risks before formal inspections.
With a proactive auditing approach, we help companies improve batch consistency, data integrity, and regulatory readiness, ensuring that your biopharmaceutical products meet the highest industry standards.
Regulatory inspections can be complex,demanding, and challenging but preparation is key to avoiding compliance issues. Our Inspection Readiness service is designed to help biopharmaceutical companies confidently face audits from USFDA, EMA, MHRA, and other health authorities.
We provide:
By strengthening your quality systems, manufacturing processes, and clinical documentation, we help ensure that your company is well-prepared for any regulatory inspection. Our team also provides real-time support during inspections to guide interactions with regulatory auditors.
Our Mock Inspections simulate real regulatory audits, allowing biopharmaceutical companies to assess their compliance posture before an official inspection. These inspections identify potential compliance risks, operational inefficiencies, delay of document retrievals for submission and review, unfriendly inspection atmostphere / setups, and documentation gaps that could lead to regulatory citations.
During our mock inspections, we evaluate:
Following the inspection, we provide a detailed report with findings, risk levels, and corrective action recommendations, ensuring that your company can address any issues proactively and maintain compliance with global regulatory expectations.
In the biopharmaceutical industry, Quality Assurance (QA) is essential and critical for ensuring product safety, efficacy / strength, and regulatory compliance. Our QA services focus on developing, implementing, and optimizing Quality Management Systems (QMS) to meet GMP, GLP, GDP, GPvP, and GCP standards.
We assist with:
By ensuring a robust QA framework, we help companies reduce product defects, product reworks, regulatory risks, and manufacturing inefficiencies and inconsistencies, ultimately improving product quality and patient safety.
Quality Control (QC) is a critical component of biopharmaceutical manufacturing, ensuring the purity, potency, and consistency of drug products. Our QC services provide analytical method validation, stability studies, microbiological testing, and compliance assessments to meet industry regulations.
Our key QC services include:
By implementing state-of-the-art effective QC procedures, we help biopharmaceutical companies ensure regulatory compliance, improve batch reliability, reproducibility, and reduce manufacturing deviations.
The biopharmaceutical industry requires highly specialized talent to drive innovation, compliance, and operational success. Our Recruiting & Staffing service helps companies find top-tier professionals in quality assurance, quality control, regulatory compliance, manufacturing, and research & development (R&D).
We specialize in sourcing candidates for roles such as:
With access to a network of highly skilled professionals, we provide permanent, contract, and project-based staffing solutions to help biopharmaceutical companies build strong teams that drive compliance, efficiency, and innovation.
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