Why Test Pharmaceuticals?
Pharmaceuticals have a direct impact on patient health and safety. Even a minor lapse in quality or compliance can lead to regulatory action, market delays, costly recalls, and a loss of trust among patients and healthcare professionals.
Without proper testing, you risk:
- Compromised drug safety and efficacy
- Regulatory non-compliance and halted approvals
- Market rejections and financial losses
- Long-term damage to brand credibility
Regular Pharmaceutical Testing Helps You Ensure:
Regular Pharmaceutical Testing Helps You Ensure:
- Ensure product safety, purity, and potency
- Maintain compliance with GMP, GLP, ISO, ICH, and Pharmacopeia standards
- Detect formulation or stability issues early
- Accelerate market entry and export readiness
- Protect brand reputation and patient trust
Types of Pharmaceutical Testing We Provide
Raw Material Testing
Why : To ensure APIs and excipients meet pharmacopeia standards.
What we test : Identity, purity, potency, microbial limits, contaminants.
Who needs it : API manufacturers, formulation units.
Finished Product Testing
Why : To confirm the final drug is safe, effective, and stable.
What we test : Assay, dissolution, disintegration, content uniformity, sterility, microbial limits.
Who needs it : Pharma manufacturers (tablets, injectables, syrups, etc.).
Stability Testing
Why : To establish shelf life and storage conditions.
What we test : Accelerated and real time stability studies, degradation profiling.
Who needs it : All pharma companies for regulatory filings.
Microbial & Sterility Testing
Why : To prevent contamination risks in sterile and non sterile products.
What we test : Sterility, endotoxins, bioburden, microbial limits.
Who needs it : Injectables, ophthalmic, and sterile dosage forms.
Utilities & Process Water Testing
Why : Water is a critical raw material in pharma and must meet pharmacopeia standards.
What we test : Purified water, WFI, clean steam, compressed gases.
Who needs it : All pharma manufacturing facilities.
Packaging & E/L Testing
Why : Packaging materials can leach chemicals that affect drug safety.
What we test : Extractables/leachables, compatibility, integrity.
Who needs it : All drug manufacturers (especially injectables, biologics).
Benefits of Testing with Prewel Labs
Accredited & Compliant
NABL certified lab aligned with global pharmacopeias (IP, USP, BP, EP).
Regulatory Confidence
Support for FDA, EMA, CDSCO, and WHO audits.
Digital Dashboard
Real time results, audit ready reports, and predictive foresight.
Patient Centric
Detect issues before they reach patients.
Faster Approvals
Reduce delays in filings and market launch.
Who We Serve
Pharma Manufacturers
Formulations, injectables, biologics, APIs
Biotech Companies
Drug development and scale up testing
Contract Manufacturers
(CMOs/CDMOs) Batch release testing
Exporters
Compliance for US, EU, and global markets
Pharma Testing at a Glance
| Test Type | Why It Matters | Key Parameters | Who Needs It |
|---|---|---|---|
| Raw Material Testing | Prevents poor quality APIs/excipients from entering production | Identity, purity, potency, microbial limits | API & formulation companies |
| Finished Product Testing | Ensures safety & efficacy of medicines | Assay, dissolution, sterility, microbial limits | Formulation manufacturers |
| Stability Testing | Establishes shelf life & storage | Accelerated, real time stability, degradation | All pharma companies |
| Microbial & Sterility Testing | Prevents contamination & patient harm | Sterility, endotoxins, bioburden | Sterile dosage manufacturers |
| Utilities & Process Water | Prevents waterborne contamination | Purified water, WFI, clean steam, gases | All pharma plants |
| Packaging & E/L | Ensures packaging safety & compatibility | Extractables, leachables, integrity | Drug & biologic manufacturers |
FAQs
What types of pharmaceutical tests do you perform?
Common categories include:
- Microbiological Testing (bioburden, sterility, endotoxin, preservative efficacy)
- Microbiological analysis of water (Potable water/Purified water/WFI/RO Water)
- Chemical Testing (assay, impurities, dissolution, stability)
- Physical Testing (hardness, friability, disintegration, viscosity)
- Raw Material Testing
- Finished Product Testing
- Stability Studies
- Packaging Material Testing
Do you offer testing for all dosage forms?
Yes. We test tablets, capsules, syrups, injectables, ointments, gels, API, bulk drugs, and medical devices, among others.
Are your test methods as per pharmacopeias?
Yes. All methods follow standard pharmacopeias such as IP, USP, BP, EP, JP, or validated in-house methods when required.
Do you provide NABL or ISO-based testing?
Depending on your region’s requirement, we offer testing under NABL-accredited and ISO/IEC 17025–compliant conditions.
What sample quantities are required?
Sample quantity depends on the test type. Typically:
- Microbiology: 20-30 gms
- Chemical: 10–20 gms
- Stability: As per study design
We share exact quantity requirements during quotation.
What is your typical turnaround time (TAT)?
TAT varies by test:
- Microbiology: 5–7 days ( If Sterility its 14 days)
- Chemical tests: 3–7 days
- Stability studies: Ongoing
Faster TAT options are available on request.
Do you offer pick-up services for samples?
Yes, we offer sample collection services across India, and through partner networks, we also support sample shipments from abroad.
Can you support regulatory submissions?
Yes. We provide COAs, raw data, protocols, validation reports, and regulatory-ready documentation to support audits and filings.
Do you handle confidential or patented products?
Absolutely. All samples and data are managed under strict confidentiality agreements and secure lab practices.
Do you offer stability studies?
Yes. We provide real-time and accelerated stability testing under ICH guidelines with controlled temperature and humidity chambers.
How do you ensure data integrity?
We follow ALCOA+ principles, audit trails, controlled documentation, and lab automation systems ensuring data accuracy and compliance.
Can you test impurities and degradation products?
Yes. We perform impurity profiling, related substances analysis, residual solvent testing, and degradation studies.
Do you support method development and validation?
Yes, we help with method development, method validation, method verification, and transfer studies.
Do you provide testing for export batches?
Yes. We test batches destined for US, EU, Middle East, Southeast Asia, and African markets, meeting global regulatory requirements.
How do we receive our reports?
Reports are shared as digitally signed PDFs, and physical copies can be provided upon request.
What are your testing charges?
Pricing depends on the test parameters, quantity, and regulatory requirements. A detailed quotation is provided after understanding your sample and needs.
Do you test packaging materials?
Yes. We test HDPE bottles, glass vials, rubber stoppers, blister packs, aluminium foils, and other primary/secondary packaging materials for compatibility and safety.
Do you handle urgent or priority testing?
Yes. We offer express TAT services depending on lab load and feasibility.
Do you provide testing services across India?
Yes. We offer pharmaceutical testing services to clients across all cities in India, including Bengaluru, Hyderabad, Mumbai, Chennai, Delhi, Ahmedabad, Pune, and more.
How can clients outside your city send samples for testing?
Clients can ship samples using approved courier partners. We provide sample packaging guidelines, temperature control instructions, and documentation support to ensure safe and compliant transit.
Do you accept samples from abroad?
Yes. We accept samples from international clients, provided they comply with customs regulations and import documentation requirements. Our team guides you through the entire process.
Do you provide technical support to international clients?
Yes. Our technical team supports clients worldwide through email, virtual meetings, and WhatsApp, ensuring seamless communication across time zones.