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.
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 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.
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.
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.
RSSL present a brief video guide to the use of biomolecule analysis to...
Extractables and Leachables – A Practical Approach
RSSL present a practical approach to testing for leachables and extrac...
Dissolution in the Characterisation of Solid Oral Dosage Forms
Oral dosage forms remain one of the most flexible and effective treatm...article posted by Reading Scientific Services Ltd (RSSL)
1500 Foreign Materials Identified
RSSL anticipates its 1500th foreign materials identification project d...article posted by Reading Scientific Services Ltd (RSSL)
Addressing the QP Shortfall
Every holder of human or veterinary Manufacturers Authorisation must h...article posted by Reading Scientific Services Ltd (RSSL)
Analysis of Residual Solvents
RSSL discuss the importance of accurate residual solvent analysis, and...article posted by Reading Scientific Services Ltd (RSSL)
Analytical Requirements for Drug-Delivery Device Manufacturer
Drug delivery devices cover a wide spectrum of technologies. Any devic...article posted by Reading Scientific Services Ltd (RSSL)
Beyond Microscopy: Analytical Capabilities at RSSL
At RSSL, visiual inspection techniques are supplemented by analytical...article posted by Reading Scientific Services Ltd (RSSL)
- Pharmaceutical Inspection
- Analytical Services
- Pharmaceutical Training
- Drug Testing
- Pharmaceutical Storage
- Pharmaceutical Laboratory Standards and Compliance
- Process Control and Automation
- Pharmaceutical Research
- Pharmaceutical Consulting
- Laboratory Analyzers
- Drug Validation
- UV/VIS Spectroscopy
RSSL Pharma Brochure
This brochure offers a range of specialist scientific services offered by RSSL Pharma including consultancy, a...
Becoming A Qualified Person
RSSL offers in-depth tuition for aspiring Qualified Persons covering a diverse range of topics from quality ma...
Orthogonal Approaches for the Analysis of Protein Sequence
RSSL present a new whitepaper on "Orthogonal Approaches for the Analysis of Protein Sequence and Post Translat...
Quality Management Systems (QMS) Lead Auditor Training Course
RSSL offer intensive 5-day lead auditor training courses offering everything you need for international recogn...
Performing an Intact Mass Analysis of a Monoclonal Antibody
RSSL present a free whitepaper on "Considerations When Performing an Intact Mass Analysis of a Monoclonal Anti...
New Guidelines Strengthen Good Distribution Practice (GDP)
Pharmaceutical, Healthcare and Supply Chain Logistics Consultant, Ciarán M Brady at RSSL presents a new white...
7 Common Myths about QP Training Debunked
RSSL, specialist providers of QP training present a free white paper - a guide for senior managers debunking 7...
Elemental Impurities Regulations: View from a CRO
Contract research organisation, RSSL, present a white paper on elemental impurities regulations discussing the...
RSSL Training Calendar 2017
Reading Scientific Services Ltd (RSSL) present their complete pharmaceutical training calendar for 2017.
Events We Are Attending
Reading Scientific Services Ltd (RSSL)
Reading Science Centre, Whiteknights Campus
RG6 6LA, Reading