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Pharmaceutical

Pharmaceutical Testing and Certification Company | ISO 17025 Pharma Lab Services

In the highly regulated pharmaceutical industry, accuracy, safety, and compliance are non-negotiable. At Inspectra Edge, we specialize in comprehensive pharmaceutical testing and certification services tailored to meet global standards, including ISO 17025 lab testing, regulatory compliance, and product safety validation. Our mission is to help pharmaceutical manufacturers, contract labs, and biotech companies bring safe, effective, and compliant products to market.

Whether you're conducting drug quality testing, requiring pharmaceutical inspection services, or setting up quality assurance for pharma labs, Inspectra Edge offers full-spectrum testing, sampling, and analysis backed by certified processes and cutting-edge instrumentation.

Comprehensive Pharmaceutical Inspection Services

Ensure consistent product quality and compliance with national and international pharmaceutical regulations. Our certified experts conduct both routine and specialized pharma inspections to verify standards across manufacturing, packaging, storage, and transportation. Our Core inspection services include:

GMP Audits and Facility Compliance Checks
Process Equipment and Cleanroom Inspection
API and Excipient Handling Validation
Packaging Integrity Inspection and Traceability Audits
Environmental Monitoring and Controlled Area Assessment
 

Pharmaceutical Product Sampling and Analysis

We offer reliable pharma product sampling and analysis services for raw materials, intermediates, and finished drug formulations. Our testing capabilities include:

 

Raw Material and API Sampling

Ensure identity, purity, and potency before formulation.

 

Finished Product Testing

Assay, dissolution, disintegration, and content uniformity.

 

Stability Studies

Real-time and accelerated studies to determine product shelf life.

 

Microbiological Testing

Total viable count, endotoxin testing, and sterility checks for injectables, creams, and tablets.

 

Extractables & Leachables

Evaluate packaging interaction with drug products under ICH guidelines.

Quality Assurance for Pharma Labs

We support pharmaceutical companies with tailored pharma quality assurance strategies to strengthen internal systems and enhance market readiness. Our QA services include:

  • SOP Development and Validation
  • Quality Risk Management and CAPA Planning
  • Internal Audit and Documentation Review
  • Laboratory Control and Data Integrity Audits
  • Batch Record Review and QMS Optimization

Regulatory Compliance Testing & Certification

Our regulatory team ensures full regulatory compliance testing aligned with FDA, EMA, MHRA, WHO-GMP, and country-specific requirements. Our Services include:

  • Method Validation and Transfer per ICH guidelines
  • Bioequivalence (BE) and Bioavailability (BA) Support Testing
  • International Pharmacopoeia Alignment (USP, EP, IP, JP)
  • Labeling and Regulatory Dossier Review
  • Technical File Preparation and Submission Support

ISO 17025 Pharmaceutical Quality Control Laboratory

Our state-of-the-art pharmaceuticals quality control laboratory operates under ISO/IEC 17025 accreditation, ensuring the highest level of traceability, reproducibility, and regulatory recognition. Our Lab capabilities include:

  • Chromatographic Analysis (HPLC, GC, UPLC)
  • Spectroscopic Testing (UV-Vis, IR, Mass Spectrometry)
  • Dissolution and Particle Size Analysis
  • Moisture, pH, and Viscosity Measurement
  • Endotoxin and Mycoplasma Testing

Why Choose Inspectra Edge for Pharmaceutical Testing?

ISO/IEC 17025 Accredited Labs with Global Reach

Expert Scientists, Regulatory Auditors, and QA Consultants

Compliance with WHO-GMP, FDA, EMA, ICH, and PIC/S Guidelines

Fast Turnaround and Customizable Testing Panels

Trusted by Pharma Manufacturers, Biotech Firms, and Exporters Worldwide

Get a Quote for Pharmaceutical Testing & Certification

Need help with pharmaceutical analysis, regulatory compliance testing, or ISO 17025 lab certification? Contact Inspectra Edge today for a customized service plan and a quote tailored to your pharma product development and market access goals.

Frequently Asked Questions (FAQ)


A:We offer testing for raw materials, APIs, finished drugs, stability studies, and microbiological assessments under ISO 17025 accreditation.

A: Yes. We assist with regulatory dossiers, technical files, method validation, and compliance documentation for FDA, EMA, and other authorities.

A: Pharmaceutical inspection includes facility audits, cleanroom checks, process validation, and GMP compliance assessments for manufacturing units.

A: Yes. We offer standardized and regulatory-compliant sampling methods for batch testing, stability, and microbiological validation.

A:Our laboratories are ISO/IEC 17025 accredited and operate in alignment with WHO-GMP and global pharmacopoeia standards.
Inspectra Edge is here to provide confidence and assurance, enabling your business to thrive in a competitive and ever-changing world. Partner with us today and experience the Inspectra Edge difference.

Inspectra Edge