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Company Connect Consultancy – Excellence in Validation
Regulatory Compliance & Audit Management Consulting Services
At Company Connect Consultancy, we provide specialized regulatory compliance services for the pharmaceutical and medical device industries. Our focus is on ensuring adherence to FDA 21 CFR Part 11 and EU Annex 11 requirements, supporting clients in meeting global regulatory expectations. Through risk-based, documentation-driven approaches, we help ensure data integrity, system validation, and audit readiness across both on-premise and cloud environments. Our services enable organizations to maintain compliance, reduce regulatory risk, and achieve operational excellence.
Why Regulatory Compliance Matters in Pharmaceuticals
Pharmaceutical compliance serves as the critical foundation safeguarding patient safety, product efficacy, and company reputation across global markets. The stakes couldn't be higher in an industry where lives depend on quality.
Non-compliance risks include devastating financial penalties, widespread product recalls, legal consequences, and irreparable damage to brand trust that can take decades to rebuild.
FDA
Food and Drug Administration enforces rigorous standards for drug safety and manufacturing quality in the United States market.
EMA
European Medicines Agency coordinates regulatory oversight across 27 EU member states, ensuring unified compliance standards.
MHRA
Medicines and Healthcare products Regulatory Agency maintains post-Brexit pharmaceutical standards and patient safety protocols.
Our Auditing Team
•39+ years of Progressive experience, in areas of Quality Assurance in the Pharmaceutical (Solid Oral GeneralTablets , Effervescent Tablets and Sachets, Lozenges, Liquid, Parenteral ) and API industry.
•Champion for Total Quality Management(TQM) and had been on Leadership position in Top Pharma COS for about two decades
•Proven successful track record of Quality Assurance and GLP in Quality Controls Laboratories in pharmaceutical industry with strong focus on Regulatory compliance's , Social Audit Compliance as per WalMart ,CVS requirements , Liaisons with regulatory bodies audits.
•Consistent contributor to implementing "Best Practices" in global working environment, which supports harmonization and growth to organization.
•Strategic thinker & pragmatic problem solver. Has a keen insight and understanding of US ,EU, cGMP requirements.
• Thorough exposure of multicultural, multinational ,challenging environment and excellent communication skills for dealing at all levels – unskilled workmen to senior employees within the organization.
•US -FDA -At Vovantis Laboratories Private Limited as Team Leader Get Approval and At Ipca Laboratories Limited for API– 2 times•TGA & MHRA –at J.B.Chemicals and Pharmaceuticals (JBCPL) -Unique Group-2 times.
•WHO- Geneva At Ipca Laboratories Limited for API & Pharma -2 times.
•MOH of Kenya, Ivory Cost ,Congo ,Sierra Leone, Uganda,Ghana, Yemen, Cameroon- more than 2 times•WHO India at Ipca, JBCPL ,Vovantis almost 7 times
●Social Audit :
●GMP Audit For Overseas Customer :•Intertek,UL and NSF GMP for CVS , Walmart , Walgreen ,Target. (overseas customer) - Get Certification and keep maintained more than 4 year.
• For CVS ,Walmart , Walgreen and Target (overseas customer) conducted by Intertek, UL Lab - successfully qualified and keep maintained more than 4 year.•Working as Neutral Auditor for Overseas Customer for Indian Supplier for Drug Products /Drug Substance(API)
●cGMP Documentation & Training For Quality System Implementation- Projects (Completed /Under Progress) For Regulatory compliance
• Train The Trainers
• Quality Management System
• Quality Risk Management
• Investigation Skills
• Stability Management
• Technology Transfer
• CAPA
• Quality by Design
• Trending and Data analysis,
• Technology Transfer,
• Strategist for quality compliance,
• Facility -Audit ,Gap Analysis , Design of Facility as per requirement Of Regulatory
• Qualification,
• Harmonization and simplification of best practices• Waste Elimination
• On Job Training To Workmen to Management Staff.*As a consultant in last five at different Organization remain Observer for USFDA ,Yemen MOH , NAFDAC ,WHO-India during Regulatory Audits ,Customers Audits and compliance prepared ,implemented ,Get Organization Approved from the Authorities. Gap Analysis for Plant Design and New section creation .
Quality Management System Document Control
The Backbone of Pharmaceutical Compliance
Change Control
Structured processes prevent unauthorized alterations that could compromise product quality, ensuring every modification follows documented approval pathways and impact assessments.
Risk Management
Proactive identification and mitigation of compliance threats through integrated risk assessment frameworks that protect both patients and business operations.
Deviation Management
Systematic tracking and investigation of process deviations enables rapid corrective actions and prevents recurring quality issues that threaten compliance.
Incident Reporting
Comprehensive incident documentation creates transparency, facilitates root cause analysis, and demonstrates proactive quality management to regulatory authorities.
Effective document control ensures complete traceability, clear accountability, and timely updates across all pharmaceutical operations, creating an unbreakable chain of quality assurance.
Vendor Management Lifecycle
Critical Responsibility: Pharmaceutical companies remain ultimately responsible for product quality, even when outsourcing manufacturing or component supply to third parties.
Competence Evaluation
Comprehensive assessment of supplier capabilities, certifications, and quality management systems before partnership initiation.
Written Agreements
Detailed contracts defining quality standards, regulatory compliance expectations, and specific responsibilities for all parties.
Performance Monitoring
Ongoing surveillance and periodic reassessment ensure suppliers maintain compliance throughout the partnership lifecycle.
Regulatory guidance from FDA Q10 and 21 CFR Part 820 emphasizes documented responsibilities and risk-based approaches that optimize resource allocation while ensuring comprehensive compliance assurance.
Data Integrity
Data integrity represents the foundation of reliable pharmaceutical operations, defined as data that maintains complete trustworthiness throughout its entire lifecycle from creation to archival.
A - Attributable
L - Legible
C - Contemporaneous
O - Original
A - Accurate
Data clearly linked to the person responsible for its generation, with electronic signatures and timestamps.
Information remains readable and interpretable throughout the entire data retention period.
Data recorded at the time of activity, preventing after-the-fact alterations or reconstructions.
First-capture data or verified true copies that maintain complete authenticity and traceability.
Data reflects true values without errors, omissions, or unauthorized modifications throughout its lifecycle.
Expanded ALCOA+ principles include Complete, Consistent, Enduring, and Available data requirements, while regulatory frameworks like FDA 21 CFR Part 11, EU Annex 11, and PIC/S guidance enforce comprehensive data integrity standards across all pharmaceutical operations.
Implementing Data Integrity Best Practices
Real-Time Recording
Electronic signatures and timestamp validation ensure data remains contemporaneous and attributable, eliminating opportunities for post-hoc manipulations that compromise integrity.
Access Controls
Robust user authentication and authorization systems prevent unauthorized data changes while maintaining comprehensive audit trails for complete accountability.
Process Automation
Automated data capture and validation systems significantly reduce human error, enhancing data accuracy and reliability across all pharmaceutical operations.
Continuous Monitoring
Real-time surveillance systems and robust backup plans protect against data loss, breaches, and unauthorized modifications throughout the data lifecycle.
Conducting Effective Data Integrity Audits
Audit Preparation
Comprehensive planning including scope definition, team assembly, and preliminary risk assessment to maximize audit effectiveness.
Documentation Review
Systematic examination of data governance policies, procedures, and historical compliance records for gap identification.
On-Site Inspection
Physical verification of data integrity controls, system configurations, and real-world implementation of documented procedures.
Staff Interviews
Structured discussions with personnel to understand actual practices, identify training needs, and assess culture of compliance.
Risk Assessment
Comprehensive evaluation of findings to prioritize corrective actions and develop targeted improvement strategies.
Identifying root causes of data integrity issues enables targeted corrective and preventive actions (CAPAs) that strengthen compliance frameworks. Multidisciplinary audit teams covering technical and regulatory aspects ensure comprehensive coverage of GMP, GLP, and regulatory expectations.
Comprehensive Audit Solutions
Audit Readiness Assessments
Pre-audit gap analysis and risk assessment using a 250-point checklist based on CFR Parts 210, 211.
Mock Audits
Simulated regulatory audits conducted by former FDA/EMA inspectors to identify vulnerabilities.
Audit Remediation
Development and implementation of CAPA plans to address audit findings and reduce remediation timelines.
Training Programs
Customized GMP, GLP, and GCP training programs for all personnel levels, enhancing knowledge retention.
Industry Expertise: Connecting Across Sectors
Biopharmaceutical Manufacturers
Assistance with GMP compliance for biologics production and regulatory adherence.
Generic Drug Manufacturers
Guidance on ANDA submissions and ensuring compliance with FDA regulations.
Contract Manufacturing Organizations (CMOs)
Support with supplier audits and compliance with stringent client requirements.
Our Services
Our CSV Consultancy Key Features
Compliance Assessment
We conduct a comprehensive assessment of your existing computer systems to identify any gaps in compliance. This assessment involves a thorough review of system documentation, processes, and controls to ensure alignment with regulatory requirements.
Validation Planning and Strategy
Based on the assessment results, we work closely with you to develop a detailed validation plan and strategy. This includes defining validation objectives, scope, deliverables, and timelines. We consider industry standards and regulatory guidelines to ensure a robust and compliant validation process.
Risk Assessment and Mitigation
We assist in identifying potential risks associated with your computer systems and their impact on data integrity, reliability, and security. Our consultants employ risk assessment techniques to prioritize risks and develop effective mitigation strategies, such as risk-based testing and validation approaches.
Standard Operating Procedures (SOPs)
We provide guidance on developing and improving documentation practices, including creating validation protocols, test scripts, and standard operating procedures (SOPs). Well-documented processes and procedures are crucial for demonstrating compliance and ensuring consistent system performance.
Validation Execution
Our experienced consultants oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing. We guide you through the testing process, ensuring adherence to protocols and best practices.
End-to-End Data Migration Services
We make your data migration stress-free with a clear plan, thorough verification, and detailed reporting. From preparing the right migration strategy to validating data accuracy and delivering transparent reports, we ensure a smooth, secure, and reliable transition for your business.
Operation & Maintenance Services
We ensure your systems run smoothly with reliable operation and proactive maintenance support. From day-to-day system monitoring to preventive maintenance and quick issue resolution, our team helps maximize uptime, extend system life, and keep your business performing at its best.
Change Control Management
We assist in establishing robust change control and deviation management processes for your computer systems. This involves defining change control procedures, documenting change requests, assessing impacts, and implementing appropriate controls to maintain system integrity.
Periodic Reviews
We conduct regular reviews of computerized systems to ensure they remain compliant, validated, and fit for use. Our periodic review services cover documentation checks, system performance, data integrity, and regulatory compliance—helping you identify risks early and maintain continuous validation.
Periodic Reviews
We help organizations safely retire and decommission outdated systems while ensuring data integrity, compliance, and business continuity. Our approach covers planning, data archiving, validation checks, and regulatory documentation—so you can securely transition without risks or data loss.
Ensure Compliance with Confidence
Request a Quote Today!
Partner with Company Connect Consultancy for expert CSV guidance, ensuring the integrity, reliability, and security of your computer systems. Our customer-centric approach helps you meet regulatory requirements while optimizing system performance and efficiency. Contact us today for a no-obligation quote!