Pharmaceutical Industry Services
Pharmaceutical Development Services
Drug Candidate Screening
SAXOCON provides a range of computer-based models to identify structural alerts and predict biological effects so that you can predictively screen for new active substances, which is key to successful drug discovery.
Impurities Safety Evaluation
SAXOCON can help you establish and document the Permitted Daily Exposure (PDE) and establish impurities limits that ensure the quality and safety of your product in accordance with regulatory requirements.
Study Sponsor Monitor
SAXOCON has the toxicological and regulatory expertise to serve as a study monitor for your products. Let us ensure your testing meets OECD GPL requirements.
Primary Packaging Safety
SAXOCON helps you to establish and document the compliance of your containers and other primary packaging systems with all relevant regulatory requirements, ensuring the safety and quality of the finished product.
Drug-Device Safety
SAXOCON can help to ensure that your devices intended to administer a drug product (combination products) comply with the regional regulation of both medicinal and medical device products. Get your drug-device product compliant quickly.
Pharmaceutical Manufacturing Services
Nitrosamine impurities
SAXOCON can check your products for the presence of highly toxic nitrosamine compounds. According to a European Medicinal Agency (EMA) review under Article 5(3) of Regulation (EC) No 726/2004, all marketing authorisation holders in the EU are required to evaluate, and potentially test for, the presence of nitrosamines.
Unexpected particulate matter findings
With a SAXOCON service level agreement (SLA), you will have everything you need to analyse and evaluate the impact of deviations or non-conformances when sudden unexpected findings of particulate matter in, or in contact with, your drug products appear.
Safe equipment and systems
SAXOCON can help you ensure that any production equipment that comes into contact with drug substances or drug products is documented compliant with any regulatory requirements.
Manufacturing change control
SAXOCON provides services that let you maintain Good Manufacturing Practice (GMP) by understanding the impact of changes, deviations or non-conformance relating to ICH Q7, Q8, and Q9.
Cleaning validation support
SAXOCON helps you to establish and document Permitted Daily Exposure (PDE) in accordance with regulatory requirements for the manufacture of medicinal products in shared facilities.
Technically unavoidable particles
SAXOCON offers services that help pharmaceutical manufacturers manage Technically unavoidable Particles (TUPs) by developing a Technically Unavoidable Particle Profile (TUPP). TUPPs proactively identify foreign particles and help suppliers with essential information to mitigate risks. Ensure product safety with a TUPP.