Our highly skilled team of analysts have decades of experience providing reliable, accurate and timely results in accordance with various major pharmacopoeia including:
• European Pharmacopoeia (EP)
• United States Pharmacopoeia (USP)
• British Pharmacopoeia (BP)
• Japanese Pharmacopoeia (JP)
• Chinese Pharmacopoeia (CP)
Each pharmacopoeia is a collection of official standards and quality specifications for any substance used within medicines in a specified country or region. This can include various products including active pharmaceutical ingredients (API), excipients, herbal drugs and finished drugs. These regulations ensure the consistent quality and efficacy of all medicines thus providing the key cornerstone of drug development safety.
Our regulatory experts keep up-to-date with changes in pharmacopeial standards, guaranteeing seamless compliance with constantly evolving global requirements.
Our testing capabilities encompass a wide range of techniques including chemical, physical, biopharmaceutical, elemental and microbiological analysis. These services support quality control throughout the pharmaceutical development and manufacturing process, from raw materials to finished products.
With years of experience working within Pharmacopeial requirements, RSSL has the ability to deliver specialised services in monograph method development, validation, and custom analytical solutions to support pharmaceutical projects at any stage. We also utilise state of the art analytical techniques such as HPLC, GC and Mass Spectrometry to ensure accurate and fit for purpose analytical testing.
Operating under a robust Good Manufacturing Practice (GMP) quality system, RSSL holds certifications from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for both human and veterinary medicinal products. We have also been inspected by the U.S. Food and Drug Administration (FDA).
As the trusted partner, RSSL offers the full range of pharmacopeia services. With decades of experience, we help you navigate the complexities of regulatory processes, avoid costly delays and accelerate time-to-market, all while safeguarding the safety and efficacy of your pharmaceutical products.
