Pharmaceutical companies must adhere to strict quality control and regulatory compliance to ensure that drugs are safe, effective, and consistent before reaching the market. Pharmaceutical Testing lab in Mumbai plays a critical role in assessing the purity, potency, stability, and safety of drugs, ensuring they meet the regulatory requirements of CDSCO, USFDA, EMA, WHO, and ICH guidelines.
In Mumbai, a key hub for pharmaceutical research and manufacturing, pharmaceutical companies need a trusted, GLP-compliant testing lab that delivers accurate and reliable results. Anazeal, India’s first customer-centric Contract Research Organization (CRO), is a leading pharmaceutical testing lab in Mumbai, offering end-to-end analytical and quality testing services to support pharmaceutical companies in achieving regulatory success and market approval.
Pharmaceutical testing ensures that drugs and raw materials comply with global safety and efficacy standards. It is a mandatory requirement for drug manufacturers to obtain approvals from regulatory agencies before launching a product.
1. Ensure Drug Safety & Efficacy – Identify impurities and ensure proper drug composition
2. Regulatory Compliance – Meet CDSCO, USFDA, EMA, WHO, and ICH guidelines
3. Quality Assurance – Maintain consistency and reliability of formulations
4. Product Stability & Shelf Life – Conduct stability studies to determine expiration dates
5. Impurity Profiling – Detect genotoxic, elemental, and residual solvents
Anazeal’s state-of-the-art pharmaceutical testing lab in Mumbai offers comprehensive analytical solutions to ensure pharmaceutical products meet global standards.
Anazeal provides GLP-compliant, regulatory-approved pharmaceutical testing services that help pharmaceutical manufacturers, biotech firms, and research organizations ensure quality, compliance, and safety.
1. Raw Material & API Testing
Ensuring the quality of active pharmaceutical ingredients (APIs) and excipients is critical for drug manufacturing. Anazeal conducts:
a. Identification & Purity Testing
b. Assay & Content Uniformity
c. Residual Solvent Testing
d. Microbial Contamination Analysis
By testing raw materials and APIs for purity and potency, Anazeal helps pharmaceutical companies maintain quality standards and avoid formulation errors.
2. Finished Product Testing
Anazeal performs comprehensive quality control testing for finished drug products, including:
a. Dissolution & Disintegration Testing
b. Potency & Assay Analysis
c. Uniformity of Dosage Forms
d. Sterility & Microbial Limit Testing
e. Endotoxin & Pyrogen Testing
By ensuring finished products meet quality, stability, and safety requirements, Anazeal helps companies secure regulatory approvals quickly.
3. Stability Studies (ICH-Compliant)
Anazeal offers ICH-compliant stability studies to determine the shelf life and storage conditions of pharmaceutical products. Services include:
a. Accelerated Stability Testing (40°C/75% RH)
b. Long-Term Stability Studies (25°C/60% RH)
c. Photostability & Forced Degradation Studies
d. Storage Under Controlled Conditions
These studies help companies meet regulatory stability requirements and ensure product quality over time.
4. Impurity Profiling & Elemental Analysis
Regulatory agencies require strict impurity control in pharmaceuticals. Anazeal provides:
a. Genotoxic & Mutagenic Impurity Testing
b. Elemental Impurity Testing (USP <232>/<233>)
c. Residual Solvent Analysis
d. Heavy Metal Contamination Testing
By detecting and quantifying impurities, Anazeal helps pharmaceutical companies comply with ICH Q3A/Q3B guidelines and ensure patient safety.
5. Microbial & Sterility Testing
Pharmaceutical products must be free from harmful microorganisms to ensure patient safety. Anazeal’s microbiology lab offers:
a. Bacterial Endotoxin Testing (BET)
b. Sterility Testing for Injectable Drugs
c. Total Viable Count (TVC) Analysis
d. Antimicrobial Effectiveness Testing
By ensuring that drugs meet microbial contamination limits, Anazeal helps companies comply with global pharmacopoeia standards.
6. Bioanalytical Testing & Pharmacokinetics
Anazeal’s GLP-compliant bioanalytical lab provides highly sensitive drug analysis for:
a. Pharmacokinetic (PK) and Bioequivalence (BA/BE) Studies
b. LC-MS/MS & HPLC-based Drug Quantification
c. Metabolite Identification & Profiling
d. Enzyme Inhibition & Induction Studies
These tests are essential for generic drug approval (ANDA) and biopharmaceutical research.
1. Customer-Centric Approach: Anazeal is India’s first customer-centric CRO, offering tailored pharmaceutical testing solutions with quick turnaround times and dedicated client support.
2. Global Regulatory Compliance: Anazeal’s testing facility meets global regulatory standards, including:
a. USFDA (United States Food and Drug Administration)
b. EMA (European Medicines Agency)
c. CDSCO (Central Drugs Standard Control Organization – India)
d. WHO-GMP (World Health Organization Good Manufacturing Practices)
e. ICH, USP, BP, EP, and JP Pharmacopoeia Standards
3. Advanced Technology & Infrastructure: Anazeal’s Mumbai facility features state-of-the-art instrumentation, including:
a. LC-MS/MS, HPLC, GC-MS for drug analysis
b. Stability Chambers for ICH-compliant testing
c. Microbiology Lab for sterility testing
d. ICP-MS for elemental impurity analysis
4. Fast Turnaround Time & Cost-Effective Solutions:
a. Rapid sample analysis & report generation
b. Affordable pricing for small and large pharmaceutical firms
c. MEfficient regulatory submission support
5. Expert Regulatory & Quality Assurance Support:
Anazeal’s regulatory specialists assist with:
a. Dossier Preparation for ANDA, NDA, and CTD Submissions
b. Regulatory Documentation & Compliance Audits
c. Quality Assurance & GMP Compliance Support
Pharmaceutical testing is a critical step in ensuring drug safety, efficacy, and regulatory compliance. As a leading pharmaceutical testing lab in Mumbai, Anazeal offers comprehensive GLP/GMP-compliant testing services, ensuring that pharmaceutical products meet global regulatory standards.
With cutting-edge technology, expert scientists, and a customer-centric approach, Anazeal provides high-quality, cost-effective, and reliable pharmaceutical testing solutions for companies seeking regulatory approvals and global market access.
If you need a trusted pharmaceutical testing lab in Mumbai, Anazeal is your ideal partner for quality, compliance, and faster market approvals.
AnaZeal Analyticals & Research Pvt. Ltd. is one of the leading Pharmaceutical testing lab in Mumbai. contact us for more details.
