Why Compliance Matters
Compliance in clinical trials and pharmaceuticals means following regulatory standards, ethical guidelines, and legal frameworks that safeguard patient safety, ensure product quality, and protect data integrity. It forms the foundation of trust between researchers, regulators, and patients worldwide.
Adhering to compliance standards ensures clinical trials are ethical, drug manufacturing is safe, and regulatory approvals are smooth. Non-compliance, however, can result in delays, financial penalties, or even halts in research and production.
50+
Regulatory frameworks
99%
Data integrity assurance
500+
Successful inspections
HIPAA
Ensure the protection of sensitive patient health information through administrative, physical, and technical safeguards. Compliance is mandatory for healthcare providers, insurers, and their business associates.
FDA 21 CFR Part 11
Regulates electronic records and electronic signatures in FDA-regulated industries, ensuring that they are trustworthy, reliable, and equivalent to paper records.
EU Annex 11
Provides guidance on computer systems used in GMP-regulated environments within the EU. Ensures that automated systems maintain data integrity and regulatory compliance.
GDPR
Protects personal data of EU residents. Organizations must ensure data privacy, transparency, and user rights in data collection, processing, and storage.
GCP
International ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Protects trial subjects and ensures credible data.
CDSCO
Regulatory authority in India governing drug approval, clinical trials, and manufacturing compliance. Ensures safety, efficacy, and quality of pharmaceuticals.