Services

GxP Auditing

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.

Inspection Readiness

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:

  • Regulatory gap analysis and risk assessments
  • Document organization and effective SOP alignment
  • Mock inspections and audit simulations
  • Staff training on inspection readiness, interactions with inspectors, regulatory expectations and best practices
  • Audit of clinical  investigator sites for documentation deficiencies
  • Audit of CROs for clinical trial compliance

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.

Mock Inspections

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:

  • Manufacturing facility and process compliance
  • Quality control (QC) and quality assurance (QA) procedures
  • Effective SOPs in all areas of operations
  • Effective and efficient use of quality systems
  • Data integrity and documentation practices
  • Deviation handling and CAPA (Corrective and Preventive Actions) management & Effectiveness
  • Change control management
  • Complaint handling and management
  • Investigator site audits
  • BIMO mock inspections for drug approval

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.

Quality Assurance (QA)

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:

  • Deviation and CAPA management
  • Change control management
  • Quality infrastructure
  • SOP development and compliance training
  • Batch record review and release processes
  • Document control
  • Internal audits
  • Effective and efficient use of Quality Systems
  • Supplier qualification, management, audits and approvals

 

Quality Control (QC)

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:

  • Analytical method development and validation
  • Method and technology transfer
  • In-process and finished product testing
  • Raw material and excipient testing
  • Qualification of analyst
  • Qualification of equipment and equipment history
  • Handling and managing Out-of-Specifications (OOSs)
  • Actions related to Out-of-Trend (OOT)
  • Microbial contamination control bioburden and endotoxin testing
  • Sterility testing
  • Investigations
  • Disinfection qualification and use
  • Microbial identification
  • Gowning qualification
  • Environmental monitoring and trending of data
  • Aspetic processing / biosterile and contamination control  
  • Utility testing and trend
  • Equipment calibration and laboratory compliance assessments

     

By implementing state-of-the-art effective QC procedures, we help biopharmaceutical companies ensure regulatory compliance, improve batch reliability, reproducibility, and reduce manufacturing deviations.

Recruiting & Staffing

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:

  • Quality Assurance (QA) & Quality Control (QC) professionals
  • Regulatory Affairs professionals
  • Bioprocess engineers and manufacturing specialists / operators
  • Clinical research associates (CRAs) and trial managers
  • Validation and compliance experts
  • Management and leadership personnel
  • Contractors & consultants

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.

GxP Auditing

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.

Inspection Readiness

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:

  • Regulatory gap analysis and risk assessments
  • Document organization and effective SOP alignment
  • Mock inspections and audit simulations
  • Staff training on inspection readiness, interactions with inspectors, regulatory expectations and best practices
  • Audit of clinical  investigator sites for documentation deficiencies
  • Audit of CROs for clinical trial compliance

 

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.

Mock Inspections

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:

  • Manufacturing facility and process compliance
  • Quality control (QC) and quality assurance (QA) procedures
  • Effective SOPs in all areas of operations
  • Effective and efficient use of quality systems
  • Data integrity and documentation practices
  • Deviation handling and CAPA (Corrective and Preventive Actions) management
  • Change control management
  • Investigator site audits
  • BIMO mock inspections for drug approval

 

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.

Quality Assurance (QA)

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:

  • Deviation and CAPA management
  • Change control management
  • Quality infrastructure
  • SOP development and compliance training
  • Batch record review and release processes
  • Document control
  • Internal audits
  • Supplier qualification, management, audits and approvals
  • Risk-based quality system optimization
  • Investigations
  • Root cause analysis
  • Validation
  • Annual product review
  • Warehousing and distribution
  • Shipping and receiving
  • Receiving and inspection of components and materials
  • Labeling and packaging

 

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)

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:

  • Analytical method development and validation
  • Method and technology transfer
  • In-process and finished product testing
  • Raw material and excipient testing
  • Qualification of analyst
  • Qualification of equipment and equipment history
  • Handing Out-of-Specifications (OOSs)
  • Out-of- Trend (OOT)
  • Microbial contamination control bioburden and endotoxin testing
  • Sterility testing
  • Investigations
  • Disinfection qualification and use
  • Microbial identification
  • Gowning qualification
  • Environmental monitoring and trend
  • Aspetic processing / biosterile and contamination control  
  • Utility testing and trend
  • Equipment calibration and laboratory compliance assessments

 

By implementing state-of-the-art effective QC procedures, we help biopharmaceutical companies ensure regulatory compliance, improve batch reliability, reproducibility, and reduce manufacturing deviations.

Recruiting & Staffing

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:

  • Quality Assurance (QA) & Quality Control (QC) professionals
  • Regulatory Affairs professionals
  • Bioprocess engineers and manufacturing specialists / operators
  • Clinical research associates (CRAs) and trial managers
  • Validation and compliance experts
  • Management and leadership personnels
  • Contractors & consultants

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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