Regulatory Affairs: Drug Safety and Quality

Resources like training, equipment, and protocols ensure smooth, efficient lab operations

Resources for Successful Lab Operations

Resources for successful lab operations enhance efficiency through effective software, skilled staff, reliable equipment, and compliance. Image for illustration only. People depicted are models.

Medical device regulation ensures safety, efficacy, compliance, and protects patient health

Regulatory Affairs

Racing Against the Clock: Reigniting Europe’s Medtech Marketplace

By Open MedScience

Medical Device Regulation ensures safety, enhances standards, fosters innovation, and supports effective healthcare delivery.

PET drug manufacturing follows strict standards under 21 CFR Part 212.

Regulatory Affairs

Ensuring Quality and Compliance: A Guide to 21 CFR Part 212 for PET Drug Manufacturing

By Open MedScience

The regulations in 21 CFR Part 212 ensure PET drugs are manufactured under strict quality control and safety standards.

GMP ensures quality, safety, consistency, and compliance in medical pharmacy manufacturing

Regulatory Affairs

Overview of Good Manufacturing Practices (GMP) in Radiopharmaceuticals

By Open MedScience

Good Manufacturing Practices ensure the consistent quality, safety, and efficacy of pharmaceutical products through rigorous production standards.

ICH Q10 ensures pharmaceutical product quality through effective management

Regulatory Affairs

The International Council for Harmonization (ICH) Q10: A Model for a Robust Pharmaceutical Quality Management System

By Open MedScience

ICH Q10 is a global model for managing pharmaceutical quality, ensuring compliance, continuous improvement, and risk manage.

The Q9(R1) guidance improves pharmaceutical quality risk management practices

Regulatory Affairs

Q9(R1) Quality Risk Management: Final FDA Guidance for Industry

By Open MedScience

Q9(R1) Quality Risk Management provides a comprehensive framework for assessing, controlling, and mitigating pharmaceutical quality risks.

ICH E8 ensures ethical, scientifically sound clinical trials globally conducted

Regulatory Affairs

Understanding ICH Guideline E8: General Considerations for Clinical Trials

By Open MedScience

ICH Guideline E8 establishes essential principles for designing, conducting, and reporting scientifically valid and ethically sound clinical trials.

The IND process ensures safe testing of drugs in humans

Regulatory Affairs

Understanding the Investigational New Drug (IND) Application

By Open MedScience

The IND application allows researchers to test investigational drugs in humans, ensuring safety and regulatory compliance throughout development.

Radioactivity measurement provides accurate data for safety and regulatory purposes

Regulatory Affairs

Radioactivity Measurement and Traceability in Radiation Science

By Open MedScience

Radioactivity measurement ensures accurate detection and quantification of radiation levels for safety and regulatory compliance.

The ICH Q7 guideline ensures quality and safety in API manufacturing

Regulatory Affairs

Understanding the International Council for Harmonisation (ICH) Q7 Guideline

By Open MedScience

The ICH Q7 guideline ensures consistent manufacturing practices, maintaining API quality, purity, and safety throughout production processes.

Radiopharmaceutical production requires strict compliance with safety and quality standards

Regulatory Affairs

Regulatory Considerations in Radiopharmaceutical Production

By Open MedScience

Regulatory radiopharmaceutical production requires strict adherence to safety standards, ensuring quality and patient safety.

Ensuring compliance in medical devices guarantees safety, quality, and regulatory approval

Regulatory Affairs

Ensuring Compliance: Industrial Challenges in Meeting EU MDR

By Open MedScience

Ensuring compliance with EU MDR poses significant challenges for medical device manufacturers, including increased scrutiny, financial strain, and data protection demands. Image for illustration only. People depicted are models.