Reading Scientific Services Ltd (RSSL)

Industry Leading Provider of Scientific Analysis, Research, Consultancy and Training Services to the Global Pharmaceutical Industry

RSSL is a trusted provider of world-class scientific and technical solutions for the global pharmaceutical, biopharmaceutical and healthcare sectors.

We understand how important it is for our customers to produce world-leading brands that are safe, innovative, of the highest quality and meet the demands of regulators.  With this in mind, we apply our trusted specialist expertise in analysis, research, consultancy and training to help achieve your commercial objectives.

As a MHRA and FDA approved organisation, we maintain our foundation in scientific excellence and quality by continually investing in technology and people.  We work with our customers to provide practical solutions, rapid results, expert interpretation and sound advice to proactively help accelerate your product lifecycle. By providing a customised and focused approach, we are trusted partners committed to developing long-lasting, mutually beneficial relationships.

 

Our extensive range of services include:

  • Analytical Services for Drug Formulation
  • Biopharmaceutical Product Analysis
  • Contamination – Chemical and Physical
  • Cleaning Validation
  • Extractables and Leachables
  • Impurity Isolation and Sample Purification
  • Medical Devices
  • Method Development and Validation
  • Microbiological Analysis
  • Pharmaceutical Training
  • Pharmacopoeial Testing to USP, EP, JP, CP
  • Physical and Structural Properties
  • Stability Storage, Management and Testing

 

Analytical Services for Drug Formulation

We ensure the quality, safety and efficacy of your drug formulation by providing analytical services that can support your clinical trials and regulatory submissions. Our expert scientists have the capability, techniques and equipment to assist with a wide range of formulation types throughout the drug development lifecycle from early phase to finished product release and import testing.  This includes comprehensive phase-appropriate analytical method development for both the active pharmaceutical ingredient (API) and the drug undergoing development.

 

Biopharmaceutical Product Analysis

To help you meet regulatory requirements for safety, efficacy and quality, we offer a portfolio of services ranging from DNA quantification, glycosylation profiling, protein and peptide analysis using chromatography, mass spectrometry, ELISA, electrophoresis and PCR techniques.

 

Contamination – Chemical and Physical

Timely and thorough scientific investigation of product contamination issues can help minimise the potential implications for your consumer and your brand. Whether chemical or physical contamination, our multidisciplinary team of experts use analytical and microscopic techniques to identify the nature and source of contaminants providing key information in order to facilitate rapid decision making.

 

Cleaning Validation

A critical aspect of quality control in manufacturing is ensuring your product is fit for release.  To help ensure that cleaning processes remove active pharmaceutical ingredient (API) residues, cleaning materials or microorganisms, we offer expert analysis of swabs, purge and rinse waters to support with validation and due diligence to reflect cGMP guidelines.  We also provide consultancy and training to support you cleaning validation processes.

 

Extractables and Leachables

Our expert capability in extractables and leachables will help maximise your chance of a positive drug registration.  We provide analytical support for all stages of the process including determination of an extractables profile, analysis of leachables within the product, quantification of amounts and establishment of biological risk.

 

Impurity Isolation and Sample Purification

Identification, isolation and purification of process related impurities can be critical to the development and manufacture of pharmaceutical products.  With our expertise in chromatographic (HPLC and ÄKTA) and spectroscopic (NMR, MS, FTIR) techniques we can support with the isolation and identification of impurities from pharmaceutical products or active pharmaceutical ingredients (APIs).  Further scale-up for isolation of larger quantities of impurities is also offered. We are able to scale-up customer specific methods or develop reproducible extraction and purification methods for your products and API’s.

 

Medical Devices

Medical device manufacture requires analytical support at every stage of the product lifecycle to comply with regulatory requirements. We work collaboratively as your partner providing scientific expertise for combination drug delivery devices to help you get regulatory approval and optimise your route to market.

 

Method Development and Validation

With many years’ experience in the pharmaceutical industry we can provide API and drug product method development, validation in line with approval protocols reflecting ICH requirements and transfer. 

 

Microbiological Analysis

In our MHRA inspected microbiology laboratory, we can ensure the quality of your pharmaceutical, medical and healthcare products.  We perform microbial limits testing for specific pathogens, bacteria, yeast and moulds at all stages of the production cycle, from raw materials to finished products. The team also offer preservative efficacy testing, endotoxin analysis, challenge testing and method development and validation.

 

Pharmaceutical Training

RSSL Training is based at our training centre in Reading. We have earned a reputation for highly interactive and relevant courses in a range of technical and business disciplines. Training for Qualified Persons (QP) is offered in 12 modules, and promises a fast-track approach to qualification. We offer a wide range of training courses including Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Auditing, Quality Assurance, Responsible Person training.

 

Pharmacopoeial Testing to USP, EP, JP, CP

Our expert team can help with cGMP quality control analysis of pharmaceuticals, biopharmaceuticals and healthcare products.  We test active pharmaceutical ingredients (APIs), excipients and drug products according to pharmacopoeia monographs and customer specific methods.

The analysis can support you throughout the development and manufacturing process, ensuring product integrity from raw material to market via excipients and API analysis, batch release, product stability studies and method development, verification and validation.

 With experienced scientists and detailed knowledge of the European Pharmacopoeia (EP), United States Pharmacopoeia (USP), British Pharmacopoeia (BP) and Japanese Pharmacopoeia (JP), we provide customers with dedicated support and advice.

 

Physical and Structural Properties

Characterising raw materials’, finished products’ and medical devices, physical and structural properties is critical for product and method developmen (including pharmacopoeial testing), routine analysis and troubleshooting manufacturing process issues. Physical analysis is necessary not just for optimising quality and performance, but in assessing how your raw materials, intermediaries and final products react to processing conditions and over shelf-life. Physical properties data plays a vital role in stability studies, batch release and method validation.

With a broad range of analytical techniques and expertise, our technical specialists can characterise the physical and structural features of excipients, APIs, combination drug delivery systems and finished pharmaceutical products.   Techniques include moisture content, particle size analysis, thermal properties, tablet hardness, viscosity and more.

 

ICH Stability Storage, Management and Testing

In accordance with cGMP and ICH guidelines, we work with customers to provide a comprehensive quality service meeting your specific stability storage and testing needs.

Our pharmaceutical product stability storage and testing services include a range of monitored temperature, humidity, and light stability storage to ICH Guidelines, covering requirements for climatic zones I to IV. We are 21CFR-compliant, and can store Schedule I to V controlled drugs.  We tailor our stability and storage testing service to meet customer needs whether it is storage only or a combination with in-house analytical testing.

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Reading Scientific Services Ltd (RSSL)
Reading Science Centre, Whiteknights Campus
RG6 6LA, Reading
United Kingdom

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