Our Premium Services
GMP Audits and Inspection Readiness
We offer comprehensive pharmaceutical auditing services, including gap assessments, inspection readiness audits, vendor audits, third-party audits, and due diligence audits. Our services cater to manufacturers of both sterile and non-sterile drug products, sterile and non-sterile drug substances, excipients, and advanced intermediates. Additionally, we audit pharmaceutical packaging materials, contract testing laboratories, as well as warehouses and distribution centres.
Quality Culture Building
We offer training sessions on quality culture building at the manufacturing site & at the corporate level to create an environment of continuous improvement, accountability, and trust.
Qualification, Validation & Technology Transfer
cGxP Lifeline offers support for all types of qualifications and validations, including analytical, process, cleaning, computer systems, facilities, and equipment, in accordance with current regulatory standards. We also provide technology transfer services for all dosage forms.
Assessment of QC Laboratories
We conduct a comprehensive gap assessment of QC laboratories, including microbiology labs, based on the principles of good laboratory practices.
Failure Investigations Review
cGxP Lifeline Consulting Services will support the investigation review process and design appropriate investigational methodologies. Additionally, we help organizations identify the root cause or probable root cause and initiate effective CAPA.
Technical Training & Capability Building
cGxP Lifeline Training Services provides essential guidance on global regulations and current cGxP practices. We offer training to the pharmaceutical industry, focusing on continuous improvement in quality and regulatory practices, in accordance with existing regulations.
Establishment of QMS & Data Governance
cGPL Lifeline is dedicated to designing and establishing quality management systems (QMS). We also offer support in designing & implementing policies and procedures that manage, safeguard, and ensure the quality and integrity of data throughout its lifecycle.
Data Integrity Assessments
We recognize the importance of data in the pharmaceutical industry. Our experts conduct comprehensive reviews of research papers and electronic data, including laboratory software, in accordance with regulatory guidelines on data integrity. We guarantee that data integrity is preserved throughout the entire product life cycle.
Simplification of Procedures within the boundaries of cGxP
cGxP Lifeline offers expert assessments to help organizations simplify their procedures and processes, ensuring compliance with current regulations while optimizing costs.
Support for Enforcement Actions
We are recognized for our compliance design, which effectively handles enforcement actions identified by international regulators. We provide support to the pharmaceutical industry by drafting technical responses to regulatory enforcement actions, including non-conformances, warning letters, and import alerts. Additionally, we represent organizations in face-to-face meetings or teleconferences with regulatory authorities.