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Data Integrity in the Life Sciences Industry “Components and the Regulatory Expectations”

Data integrity is an essential aspect of ensuring the accuracy, reliability, and consistency of data across various fields, including the life sciences industry. Regulatory bodies…
Why GxP Cellators

CQV: The Art of Balancing Efficiency and Safety in a New Facility

Commissioning, Qualification, and Validation (CQV) are essential steps in the lifecycle of a new facility, ensuring that it operates safely and efficiently according to predefined…

Computerized systems: Designing a well-structured privileges matrix for computerized systems

Designing a privileges matrix for computerized systems is a critical process that involves defining and assigning access rights to different users or groups within the…

Computerized System Validation: Navigating the Regulatory Landscape

Computerized System Validation (CSV) is a critical process in the life sciences and pharmaceutical industries to ensure that computerized systems, such as software and hardware…

Compressed Gases: Qualifications and the Regulatory requirements

The U.S. Food and Drug Administration (USFDA) sets regulatory requirements for various aspects of the pharmaceutical industry, including the qualification of compressed gases used in…

Comprehensive Guide to Pharmaceutical Process Validation

Process Validation in Pharmaceutical Industry Process validation plays a vital role in ensuring the quality, safety, and efficacy of pharmaceutical products. It is a systematic…
common gmp compliance issues In Pharmaceutical Industry

Common GMP Compliance Issues In Pharmaceutical Industry

In the world of pharmaceutical manufacturing, adhering to Good Manufacturing Practices (GMP) is of utmost importance to ensure the safety, efficacy, and quality of pharmaceutical…
CMC Regulatory Compliance in Pharmaceutical Industry

CMC Regulatory Compliance in the Pharmaceutical Industry

In the intricate landscape of pharmaceutical development, Chemistry, Manufacturing, and Controls (CMC) regulatory compliance stands as a cornerstone for ensuring the safety, efficacy, and quality…

CMC in Pharma: Ensuring Quality & Safety of Pharmaceutical

What is cmc in pharma? CMC stands for Chemistry, Manufacturing, and Controls. It is a critical component of drug development that ensures the quality and…

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