Pharmaceutical

At Inspectra Edge, we deliver flexible GLP, GCP, and GMP services, supply chain audits, and regulatory guidance to support pharmaceutical and biopharmaceutical development and manufacturing. Our expertise ensures that your products meet global standards for safety, quality, and efficacy.

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End-to-End Pharmaceutical Services

Our scientists and regulatory experts work with you at every stage of development, providing tailored services to help you achieve a competitive advantage. With over 30 years of experience, we’ve supported some of the world’s largest and most innovative pharmaceutical companies through:

• Good Laboratory Practice (GLP)
• Good Clinical Practice (GCP)
• Good Manufacturing Practice (cGMP)

Inspectra Edge’s global network of laboratories delivers unparalleled quality and reliability in testing, analysis, and certification.

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Our Pharmaceutical Solutions

GMP and CMC Laboratory Services

We provide regulatory-driven, phase-appropriate laboratory services for CMC programs, including:

• Method Development and Validation
• Stability Studies
• Extractables and Leachables Analysis
• Impurity Testing and Elemental Analysis
• Batch Release Testing

Our expertise extends to complex medicines and drug delivery systems, including inhalation products and biologics.

Biopharmaceutical Services

With advanced protein analysis and compliance with ICH Q6B guidelines, we support the characterization and testing of:

• Antibodies and Bispecifics
• Oligonucleotides
• Cell and Gene Therapies
• Vaccines and Viral Species

From stability testing to bioanalytical pharmacokinetics, we ensure your biologics are safe, effective, and compliant.

Bioanalysis Services

Our bioanalysis experts design and manage strategic programs for preclinical and clinical development. Services include:

• Immunochemistry and Biomarker Assays
• Bioanalytical Studies for Biologic Medicines

Auditing and Supply Chain Transparency

Inspectra Edge’s auditing solutions ensure a clear view of your supply chain, helping you mitigate risks through:

• Private and Shared Audit Programs
• Remote Audits and Audit Report Purchase
• Internal Audit Development

From discovery to commercialization, our regulatory consultants provide cost-effective solutions to fast-track your products to market while ensuring global compliance.

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Manufacturing and Post-Production Support

Inspectra Edge offers expert cleanroom services, equipment calibration, and eLearning modules to help your team meet efficiency, safety, and compliance goals. Additional services include:

Our services span the entire project lifecycle:

At Inspectra Edge, we deliver innovative solutions with precision, speed, and passion. By meeting your outsourcing requirements with unmatched expertise, we empower your pharmaceutical business to thrive in a competitive global market.

Choose Inspectra Edge as your trusted partner for quality, safety, and success in pharmaceutical development and production.