QC / QA
At Unimark, quality is not just a goal; it’s a commitment embedded in every step of our pharmaceutical manufacturing process. We adhere to the highest industry standards, employing state-of-the-art technologies and rigorous quality control measures to ensure that each product meets and exceeds regulatory requirements.
Quality is the cornerstone of our operations. Our dedicated quality assurance teams meticulously monitor and control every stage of production, ensuring that each product leaving our facilities meets the highest standards of safety, efficacy, and purity. We have implemented robust quality management systems to guarantee consistency and compliance with regulatory guidelines.
Regulatory Affairs
Pharmaceutical Regulatory Affairs (RA) is a critical component of the pharmaceutical industry that involves ensuring compliance with various regulations and laws related to the development, manufacturing, and marketing of pharmaceutical products. The primary goal of Regulatory Affairs is to safeguard public health by ensuring that pharmaceutical products are safe, effective, and of high quality.
Unimark Remedies regulatory affairs professionals has a strong understanding of science, medicine, and the regulatory environment. We have excellent communication and organizational skills, and we often work with cross-functional teams and interact with regulatory authorities. Keeping up with the evolving regulatory landscape is crucial for these professionals to navigate the complex process of bringing pharmaceutical products to market and ensuring their continued compliance.
QC / QA - Analytical Capabilities
Leadership is the capacity to translate vision to reality and we believe “Together we can improve the quality of life”
CHARACTERIZATION
• API’s
• Impurities
• Photo Stability
• Degradants
• Particle Size
• Nitrosamine Studies
STABILITY
• ICH Storage
• Forced Degradation
• Sterile
METHODS
• Development
• Validation
• Stability Indicating
• Cleaning
• Particle Size
• Method Validation
INSTRUMENTATION
• NMR(300MHz)
• LCMS(Quadruple)
• ICP
• Particle Size
• Analyzer
• GC MS
• XRPD
• DSC
• TGA
• Preparative PLC
• System
• HPLC
Under Renewal
Under Renewal
Under Renewal