AN ISO 9001:2015 CERTIFIED
Company Connect Consultancy
Pharmaceutical Validation
Pharmaceutical Validation Consulting Services
Ensure regulatory compliance and operational excellence with our comprehensive validation solutions, designed specifically for pharmaceutical, biotech, and clinical laboratories. We provide end-to-end validation services that align with global regulatory standards, ensuring your systems, processes, and instruments perform reliably and consistently. Our expert team helps you mitigate risk, maintain data integrity, and achieve audit readiness while optimizing efficiency. With a focus on quality and compliance, we empower your laboratory to operate with confidence and deliver accurate, reproducible results every time.
Complete Validation Excellence
Industry Leadership
Our validation services meet FDA, EMA, and ICH guidelines, supporting laboratories in maintaining the highest standards of quality and compliance. With decades of combined expertise, we deliver validation protocols that withstand regulatory scrutiny while optimizing operational efficiency.
End-to-End Support
​From initial risk assessment through final documentation, our team provides comprehensive validation support. We ensure your critical systems meet all regulatory requirements while minimizing production disruptions and accelerating time-to-market for your products.
Our Core Validation Services
Process Validation
Manufacturing process qualification and continued process verification
Cleaning Validation
Equipment cleaning procedures and residue analysis protocols
Analytical Method
Method development, qualification, and transfer validation
CSV Services
Software validation and 21 CFR Part 11 compliance
Process Validation
Stage 1: Process Design
Define the commercial manufacturing process based on development knowledge and scale-up studies
Confirm the process design through Installation Qualification, Operational Qualification, and Performance Qualification
Stage 3: Continued Verification
Stage 2: Process Qualification
Ongoing assurance that the process remains in a state of control during routine production
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Our process validation services ensure your manufacturing operations consistently produce products meeting predetermined quality attributes. We employ risk-based approaches aligned with FDA guidance and ICH Q8-Q11 principles, providing robust documentation packages that demonstrate process understanding and control.
Analytical Method Validation
Precision You Can Trust
Our analytical method validation services establish documented evidence that your testing methods are suitable for their intended purpose. We evaluate specificity, linearity, accuracy, precision, range, detection limits, and robustness according to ICH Q2(R1) guidelines.
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From HPLC and GC methods to microbiological assays and dissolution testing, we provide comprehensive validation protocols and reports that satisfy regulatory expectations. Our expertise spans raw materials testing, in-process controls, and finished product release testing.
Method Development
•Protocol design and optimization
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•Instrument qualification support
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•Reference standard qualification
Validation Execution
•Complete parameter testing
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•Statistical analysis and trending
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•Comprehensive reporting
Transfer Services
•Multi-site method transfer
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•Comparative testing protocols
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•Training and documentation
Cleaning Validation Services
Prevent Cross-Contamination
Effective cleaning validation is critical for preventing product cross-contamination and ensuring patient safety. Our experts develop scientifically sound cleaning validation programs that demonstrate your cleaning procedures consistently remove residues to acceptable levels.
Residue Identification
Establish worst-case products and critical cleaning parameters
Protocol Development
Design sampling strategies and analytical methods for residue detection
Acceptance Criteria
Calculate scientifically justified limits using toxicological data
Validation Execution
Conduct studies and provide comprehensive documentation packages
Computerized System Validation
Data Integrity Assurance
In today's digital laboratory environment, computerized system validation (CSV) is essential for ensuring data integrity and regulatory compliance. Our CSV services cover laboratory information management systems (LIMS), chromatography data systems (CDS), electronic batch records, and manufacturing execution systems.
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We follow GAMP 5 principles and satisfy 21 CFR Part 11 requirements for electronic records and signatures. Our risk-based approach focuses validation efforts where they matter most, optimizing resources while maintaining compliance.
Requirements Specification
User requirements, functional specifications, and risk assessments
IQ/OQ/PQ Execution
Installation, operational, and performance qualification testing
Ongoing Compliance
Change control, periodic review, and audit trail management
Critical Utility System Validation
HVAC, Compressed Air & Water Systems
Critical utility systems require rigorous validation to ensure they consistently deliver the required quality for pharmaceutical manufacturing. Our utility validation services encompass heating, ventilation, and air conditioning (HVAC) systems, compressed air systems, and water systems including purified water (PW) and water for injection (WFI).
HVAC Validation
Cleanroom qualification, temperature and humidity mapping, differential pressure verification, HEPA filter integrity testing, and airflow pattern studies ensuring environmental control.
Compressed Air Validation
Quality testing for oil, water, and particulate content. Microbiological monitoring, dewpoint verification, and pressure drop studies ensuring compressed air meets USP specifications.
Water System Validation
Distribution system qualification, chemical and microbiological testing, sanitization validation, and biofilm prevention strategies for purified water and WFI systems.
Why Partner With Us
First-Time Approval Rate
Our validation packages consistently pass regulatory inspections
Time Savings
Projects Completed
Successful validation projects across pharmaceutical and biotech sectors
Streamlined protocols reduce validation timeline compared to industry average
Expert Team
Our validation specialists bring extensive pharmaceutical industry experience and deep regulatory knowledge. We stay current with evolving FDA and EMA expectations, ensuring your validation programs reflect the latest regulatory thinking and industry best practices.
Flexible Engagement
Whether you need full-service validation support or targeted assistance with specific projects, we tailor our services to your needs. From single-system validations to comprehensive facility qualifications, we provide the expertise and resources to ensure success.