Neftaly: Regulatory Requirements for Drug Testing
Drug testing is a critical component of pharmaceutical development, ensuring the safety, efficacy, and quality of drug substances and finished products. At Neftaly, we operate in full alignment with global regulatory requirements to deliver drug testing services that are scientifically sound and legally compliant.
From preclinical studies to post-marketing surveillance, we uphold the highest standards to support the successful approval and lifecycle management of pharmaceutical products.
⚖️ Why Regulatory Compliance Matters in Drug Testing
Regulatory agencies such as the FDA, EMA, SAHPRA, and WHO require strict adherence to drug testing protocols to:
- Protect patient safety and public health
- Ensure consistency and quality in pharmaceutical products
- Support the approval process for new drugs
- Enforce accountability across the supply chain
Non-compliance can result in:
- Trial delays or rejections
- Product recalls
- Fines or sanctions
- Damage to reputation and patient trust
???? Neftaly’s Compliance with Regulatory Drug Testing Requirements
✅ 1. Good Laboratory Practice (GLP)
We comply with OECD GLP principles for non-clinical safety testing, ensuring that:
- Studies are conducted under controlled conditions
- Data is accurate, traceable, and auditable
- Facilities, equipment, personnel, and documentation meet global standards
✅ 2. Good Manufacturing Practice (GMP) Testing
All drug testing on commercial and clinical batches complies with cGMP regulations, including:
- Raw material and finished product testing
- In-process and stability testing
- Batch release criteria and specifications
✅ 3. ICH Guidelines
We follow the International Council for Harmonisation (ICH) guidelines, including:
- ICH Q2(R1): Validation of analytical procedures
- ICH Q3A/B: Impurity testing
- ICH Q1A–F: Stability testing
- ICH M7: Assessment of mutagenic impurities
These guidelines ensure that analytical methods are validated for accuracy, precision, specificity, linearity, range, and robustness.
✅ 4. Bioanalytical Method Validation
For clinical and bioequivalence studies, our labs follow:
- FDA and EMA bioanalytical method validation guidance
- Requirements for selectivity, accuracy, precision, sensitivity, and stability in biological matrices
✅ 5. Data Integrity (ALCOA+)
All drug testing data is generated and managed in accordance with ALCOA+ principles, meaning it is:
- Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
Electronic records are stored with secure access, audit trails, and backup systems to ensure traceability.
✅ 6. Regulatory Documentation and Reporting
- Neftaly prepares full validation packages, certificate of analysis (CoA), and study reports for submission.
- All documentation meets the formatting and content requirements for regulatory filings (e.g., eCTD, Module 3 data).
- We support clients during regulatory inspections, audits, and marketing authorization submissions.
???? Global Regulatory Alignment
Neftaly’s drug testing services meet the requirements of:
- U.S. FDA (21 CFR Parts 210, 211, 58)
- European Medicines Agency (EMA)
- South African Health Products Regulatory Authority (SAHPRA)
- Health Canada, MHRA, PMDA, TGA
- World Health Organization (WHO) for global product registration
???? The Neftaly Advantage
Our regulatory-aligned drug testing services offer:
- Faster submissions and approvals
- Reduced compliance risks
- Trusted results for global markets
- Expert support during audits and reviews
✅ Neftaly — Science That Meets Regulatory Expectations
We don’t just test drugs—we validate quality, compliance, and trust. Neftaly’s laboratory infrastructure, skilled professionals, and regulatory expertise ensure that every data point meets the standards of science and the demands of law.