Our team of subject matter experts and industry veterans provides a full range of mission-critical services to the regulated industry. We work with our clients to design and implement effective & efficient business processes, assuring sustainable compliance though optimal integration of scientific, technical & regulatory principles.

Industry leading excellence in GxP Data Integrity services for Regulatory compliance.

With compliance and oversight agencies raising their data integrity expectations and broadening their coverage, we help you more broadly to manage your vulnerabilities and risk across your organisation's operations and for all GxP data.

We offer a plethora of analytical services with unsurpassed accuracy resulting in optimum performance and predictable operational execution. By leveraging your data sources to best evaluate the design of protocols, we help reduce complexity while identifying gaps & providing actionable alternatives.

From initial development to sampling to final release, meeting biopharmaceutical development milestones, and complying with regulatory guidelines demands quality data to aid informed decision-making. Our wide range of bio monitoring services focus on addressing the challenges of auditing and quantifying identity, purity, quality, safety, efficacy and many others.

We provide services for complete due diligence audits to support any strategic mergers and acquisitions.

We guide you though the assessment of target organisation, facilities and gaps in compliances, remediation plans, management control, personnel capabilities, Supply chain & product pipeline capabilities.

We provide our clients with quality assurance and control offerings, such as evaluation of written procedures and standard operating procedures, development of laboratory systems and specifications, corporate oversight programs, and more.

We offer our clients facilities design or validation services, including a full complement of capabilities from development of requirements to auditing during construction and installation.

We advise our clients for infrastructural and engineering designs for their plants. 

We provide our clients with system and process validation or qualification services, including programmatic assistance, computer system validation, and specific validation/qualification activities.

We provide training services, including programs to address compliance and regulatory affairs, as well as custom programs to meet specific requirements.

We provide excellent candidates, tailor suited to your needs & roles.

We offer FDA-related services to clients, such as document preparation/reviews, audits and reviews, compliance problem resolution, training, regulatory affairs strategic assistance, preparation and/or review of regulatory filings, and other special services.

We offer QMS, DMS CSV, SQA Testing, Robotic Process Automation (RPA) bots, IT Infrastructure Qualification services to keep your organisation at the very edge of the technological advancements.

Our team ensures Inspection Readiness to meet quality standards through proactive risk management and streamlining of processes for a successful Inspection outcome.