Pharmaceutical Industry Dynamics and Expertise

Drug Development and Lifecycle Management: Creatigrity Technologies excels in supporting clients through the entire drug development lifecycle, including:

• Drug discovery and preclinical research.
• Clinical trials (Phases I-IV) management and support.
• Post-market surveillance and lifecycle management.

Regulatory Affairs and Compliance: Their expertise includes navigating the complex regulatory landscape, ensuring compliance with key regulations such as:

• 21 CFR Part 312 (Investigational New Drug Application).
• 21 CFR Part 314 (New Drug Application).
• 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals).
• International Conference on Harmonisation (ICH) guidelines, including ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System).

Clinical Trials Management: Creatigrity Technologies offers comprehensive clinical trial management services, including:

• Protocol development and study design.
• Regulatory submissions and Institutional Review Board (IRB) approvals.
• Site selection, patient recruitment, and data management.
• Monitoring and reporting of adverse events.

Quality Assurance and Quality Control: Their quality management systems ensure compliance with global standards such as:

• ISO 9001 (Quality Management Systems).
• ISO 17025 (General requirements for the competence of testing and calibration laboratories).
• Implementation of robust Corrective and Preventive Actions (CAPA) and continuous improvement processes.

Good Manufacturing Practices (GMP): Adherence to GMP standards is a cornerstone of their operations, encompassing:

• Facility design and qualification.
• Equipment validation (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)).
• Process validation and continuous process verification.

Pharmacovigilance: Creatigrity ensures rigorous pharmacovigilance practices to monitor the safety of pharmaceutical products post-approval, including:

• Adverse event reporting and management.
• Risk management plans and periodic safety update reports (PSURs).
• Signal detection and risk-benefit analysis.

Analytical and Bioanalytical Services: They offer a wide range of analytical and bioanalytical services, including:

• Method development and validation.
• Stability studies and impurity profiling.
• Bioavailability and bioequivalence studies.

Manufacturing and Supply Chain Management: Creatigrity Technologies excels in optimizing manufacturing and supply chain processes to ensure efficiency and compliance, including:

• Scale-up and tech transfer.
• Inventory management and distribution.
• Cold chain logistics and temperature-controlled storage.

Risk Management: Adherence to ISO 14971 standards for comprehensive risk management throughout the product lifecycle, including identification, assessment, and mitigation of risks associated with pharmaceutical products.

Regulatory Submissions and Approvals: Expertise in preparing and submitting regulatory dossiers, ensuring timely approvals from regulatory authorities such as:

• The U.S. Food and Drug Administration (FDA).
• The European Medicines Agency (EMA).
• The Medicines and Healthcare products Regulatory Agency (MHRA).
• Other regional regulatory bodies.

With their comprehensive expertise and dedication to quality, Creatigrity Technologies Pvt Ltd stands out as a leader in the pharmaceutical industry, ensuring that every aspect of drug development, manufacturing, and post-market surveillance meets the highest standards of safety and compliance.