Our End-to-End Testing Services: From Import to QP Release

Analytical Method Transfers

All pharmaceutical materials entering the UK must undergo full product specification testing before released into the market.

At Sciom, our finished product testing services include:

• Analytical Method Transfers per client/CMO Methods.
• Assay, Related Substances, Dissolution using validated analytical methods by HPLC, GC, LCMS and GCMS.
• Microbiological examination, for MLT testing, BET and Sterile Testing.

Analytical Method Development & Validation

Reliable, reproducible analytical methods are critical to product quality and regulatory compliance.

Our method development and validation services cover:

• Custom method development for APIs, excipients, and finished products
• Full ICH-compliant validation (specificity, accuracy, linearity, precision, robustness)
• Analytical transfer support and troubleshooting for in-use methods

These services form the backbone of accurate product characterization, dissolution profiling, and release testing.

Chemical, Physical, and Microbiological Testing

Sciom performs a full suite of chemical and physical testing for a wide range of dosage forms:

• Tablets, capsules, injectables, creams, Solutions, and suspensions
• Assay, content uniformity, dissolution, disintegration, Sub-visible Particles, Osmolality and weight variation
• All EP and BP testing as per the requirements

In addition, our microbiological testing services include:

• Bioburden testing and sterility assurance
• Preservative efficacy testing (PET)
• Microbial limits testing for non-sterile products

All testing is performed in Sciom’s GMP-compliant laboratories using validated equipment and techniques.

Pharmaceutical Stability Studies

Sciom provides ICH-compliant pharmaceutical stability studies to support regulatory submissions and shelf-life determination.

Our services include:

• Long-term, intermediate, and accelerated stability testing under ICH conditions:
  • 25°C / 60% RH
  • 30°C / 75% RH
  • 40°C / 75% RH

  Conducted in fully qualified stability chambers with 24/7 environmental monitoring.

• End-to-end support - from stability protocol development to final stability summary reports aligned with ICH guidelines
• Storage capabilities for ICH Zone II and Zone IVb conditions.

With comprehensive environmental monitoring and scheduled testing at defined intervals, Sciom generates robust and reliable data to support product labelling, shelf-life assignment, and global regulatory compliance.

Batch Release Testing

Batch release testing is a critical quality control step in pharmaceutical manufacturing. It verifies that each production batch meets all defined quality attributes before it is certified for release. This process safeguards patient safety and supports regulatory compliance in global markets.

Sciom conducts batch release testing to confirm:

• Full registered product specification
• Analytical data aligns with registered dossiers
• Results are reviewed and approved by quality professionals
• We prepare and approve a fully compliant Certificate of Analysis for each batch, serving as formal evidence of product quality.

With our GMP-compliant laboratory and commitment to regulatory excellence, Sciom provides a reliable, efficient, and compliant batch release testing service. Our rigorous processes ensure the quality, consistency, and traceability of every product you bring to market.

QP Release Services

The Qualified Person (QP) plays a legally mandated role in ensuring product safety and compliance with EU and UK GMP standards.

Sciom’s QP release services provide:

• Full review of manufacturing and testing documentation
• Verification of compliance with the Marketing Authorization
• Issuance of the QP Certificate of Release (per EU Directive 2001/83/EC and HMR 2012)
• Liaison with regulatory bodies such as the MHRA and EMA

Our QPs have decades of experience in overseeing commercial and clinical supply chains, ensuring peace of mind and market readiness.

Pharmacovigilance Support

In addition to product release and compliance services, Sciom provides expert pharmacovigilance support to help clients meet post-marketing surveillance obligations. Our team assists in the collection, monitoring, and evaluation of adverse event reports in line with EMA and MHRA guidelines.

We support the preparation of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and maintain compliance with Good Pharmacovigilance Practice (GVP) standards.

Sciom ensures your pharmacovigilance system is audit-ready, responsive, and aligned with global regulatory expectations—safeguarding patient safety and product integrity throughout the product lifecycle.

Why Choose Sciom?

Sciom is a trusted partner for pharmaceutical companies seeking speed, reliability, and regulatory confidence.

Key advantages include:

• End-to-end solutions: From import testing to QP release in one facility
• MHRA-approved GMP lab with modern instrumentation
• Multidisciplinary expertise across QC, Microbiology, QA, Regulatory Affairs, and QP services
• Fast turnaround times and bespoke service packages
• Compliant with MHRA, EU GMP, ICH, and global regulatory standards

Our integrated services remove complexity and streamline the path from raw materials to market release.