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

Import Testing & Raw Material Verification

All pharmaceutical materials entering the UK must undergo rigorous testing before being used or released into the market.

At Sciom, our raw material testing services include:

• Identification testing per BP, EP, or USP monographs
• Assay and purity analysis using validated analytical methods
• Contaminant screening, including heavy metals, solvents, and microbiological limits
• Microbiological examination for non-sterile raw materials

These controls ensure that only compliant, quality-assured inputs enter your manufacturing process, mitigating risks early in the supply chain.

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, gels, and suspensions
• Assay, content uniformity, dissolution, disintegration, and weight variation
• Particle size distribution and pH measurement

In addition, our microbiological testing services include:

• Bioburden testing and sterility assurance
• Preservative efficacy testing
• 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 offers ICH-compliant pharmaceutical stability studies to support regulatory submissions and shelf-life determinations:

• Long-term and accelerated stability protocols
• Dissolution and impurity profile tracking over time
• Storage under ICH Zone II and IVb conditions

With comprehensive monitoring and regular interval testing, we provide robust data to support product labels, expiry dates, and global regulatory compliance.

Batch Release Testing

Before any batch can be released to the market, it must pass stringent quality control criteria.

Sciom conducts batch release testing to confirm:

• Product meets approved specifications (assay, dissolution, microbiological limits)
• Analytical data aligns with registered dossiers
• Results are reviewed and approved by quality professionals

This ensures the integrity and consistency of every production batch.

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 Authorisation
• Issuance of the QP Certificate of Release (per EU Directive 2001/83/EC)
• 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, QA, Regulatory Affairs, and QP services
• Fast turnaround times and bespoke service packages
• Compliant with EU GMP, ICH, and global regulatory standards

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