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PRODUCTS

Lab Test Service

Global Lab Testing Solutions for Compliance and Precision

Global Pharmaceutical Lab Solutions | FDA/CE Compliant & GMP Certified

APEXVIA’s Pharmaceutical Lab Test Services are fully compliant with FDA, CE, GMP, and ISO 17025 standards. By offering comprehensive testing for APIs, excipients, packaging, and machinery, we help pharmaceutical exporters enter global markets efficiently. Moreover, our services provide regulatory support, ensuring both compliance and high product quality.

Pharmaceutical Lab Test Services

Quality and compliance are our top priorities. At APEXVIA, cGMP laboratories perform API and excipient testing, stability studies, and QC lab services. Additionally, we guide clients through FDA and CE registration, accelerating drug development and facilitating international market entry. With years of experience, our team ensures that testing processes are robust, reliable, and aligned with global standards.

API & Excipient Testing Services

Purity, impurity, and stability studies are conducted according to ICH guidelines. Furthermore, excipient-API compatibility testing guarantees formulation safety. Clients also benefit from support with FDA DMF submissions, pharmacopoeia compliance, and essential export documentation, which simplifies international regulatory approvals. In particular, our custom testing protocols address complex formulations and biosimilars.

Pharmaceutical Machinery Calibration Services

APEXVIA evaluates seal integrity, sterilization, and shelf-life for both packaging and medical devices. In addition, biocompatibility and functional performance tests support CE marking and MDR compliance. Consequently, validation reports reduce approval delays and help products achieve smooth export readiness. Our team also advises on packaging material selection to enhance product stability and safety.

Pharmaceutical Machinery Calibration Services

IQ/OQ/PQ testing, cleanroom validation, and electrical/EMC testing are provided for all types of pharmaceutical machinery. As a result, GMP-compliant calibration reports ensure reliable operation and facilitate FDA and CE approvals. Furthermore, our services include preventive maintenance guidance and technical documentation support, helping clients maintain consistent product quality.

Service Advantages

Comprehensive Testing: APIs, excipients, packaging, and machinery with focus on stability, biocompatibility, and material compatibility

Regulatory Compliance: Adheres to FDA, EMA, CE, ISO, and GMP standards

Expert Scientific Support: Guidance from regulatory and technical teams ensures accuracy throughout testing and reporting

Fast Turnaround: Results typically delivered within 24–72 hours

Custom Protocols: For biosimilars, CE-marked devices, and specialized formulations

Global Certification Support: FDA DMFs, CE dossiers, and Free Sale Certificates

Cost Efficiency: Multiple services under one roof reduce costs and streamline workflows

Service Applications

Our services assist API suppliers, excipient traders, packaging manufacturers, and machinery distributors. Furthermore, expertise in sterilization validation, QC testing, and regulatory support ensures that high-quality products are ready for global markets. In addition, our solutions help manufacturers optimize production processes, enhance product stability, and minimize regulatory risks.
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