Our Premium Services
Auditing And Inspection Readiness
We provide authoritative pharmaceutical auditing services like gap assessments, inspection readiness audits, vendor audits, and thirty-party audits for all sterile & non-sterile manufacturers. We are specialized consulting services available for Formulation, API, Intermediates, Key starting materials, Excipients, Packaging materials, analytical services, Good Distribution practices & cGxP services.
Remediation & Culture Building
We are known for the compliance design to handle enforcement actions identified by international regulators. We are experts in culture building at the manufacturing site & at the corporate level through proper remediation plans.
Qualification, Validation & Technology Transfer
cGxP Lifeline will provide support for all forms of qualifications & validations like analytical, process, cleaning, computer system, facility & equipment as per current regulatory standards. We provide technology transfer services for all dosage forms.
Assessment Of Laboratory Controls (GLP)
We work seamlessly with our professionals for a comprehensive assessment of analytical laboratory procedures including review & evaluation of analytical data based on the principle of good laboratory practices.
Failure Investigations Review
cGxP Lifeline consulting services will provide support in the investigation review process as well as design correct investigational methodology. At the same time, we support organizations to identify the adequate root cause & initiate effective CAPA.
Technical Training & Capability Building
cGxP lifeline training services deliver the instruction needed to fully understand global regulations and cGxP practices. We impart training to the life science industry for continuous improvements in quality & regulatory practices as per current regulations.
Establishment Of QMS & Digital Transformation
cGxP Lifeline ensures the design & establishment of the QMS system. We also provide support in digital transformation like eQMS & LIMS across the pharmaceutical industry.
Data Integrity Assessments
We understand the criticality of data in the pharmaceutical industry. Our experts conduct a thorough review of papers and electronic data including laboratory software as per regulatory data integrity guidelines. We ensure that data integrity is maintained throughout the product life cycle.
Simplification Of Procedures Within The Boundaries of cGxP
cGxP Lifeline provides expert assessments that help organization simplify their procedures & processes to ensure that organizations meet all the requirements of current regulations with optimized cost.
Support For Enforcement Actions
We support the pharmaceutical industry as it transitions from conventional to comprehensive global regulatory standards. We provide support to the pharma industry to draft technical responses against the enforcement actions imposed by the regulators, like NCs, warning letters, import alerts etc. We also participate in face-to-face meetings or teleconferences with regulators on behalf of organizations.