Services

Our Services

We help clients take their ideas for novel drugs through the clinical steps required to prove that a new medicine is effective and safe for use. Our state-of-the-art facility permits a wide range of specialist services for integrated end-to-end solutions. By combining services, we can remove the time delay caused by a large chain of suppliers. The teams at Arcinova are based on the same site, allowing them to efficiently work together to ensure that each drug substance or drug product passes through development stages quickly. We are also highly adaptable, providing bespoke services for customers who need to overcome specific challenges.

14C RADIOLABELLING

STABLE ISOTOPIC LABELLING

Our isotopic labelling services support drug metabolism and pharmacokinetic studies. Find out more about our offerings here:

READ MORE

PROCESS RESEARCH AND DEVELOPMENT

GMP AND NON-GMP MANUFACTURING

KILO LAB/ PILOT PLANT MANUFACTURE

SOLID STATE SERVICES

STABILITY TESTING

We offer full drug substance synthesis, developing the most economical route aligned to our scale up and manufacturing facilities. Find out more about our services here:

READ MORE

FORMULATION DEVELOPMENT

PHYSICAL AND MOLECULAR CHARACTERISATION

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Our molecule development and formulation services determine how best to formulate APIs and define their stability characteristics. Find out more about our individual offerings here:

READ MORE

ORAL AND IV CLINICAL MANUFACTURING

QC TESTING AND QP RELEASE

STABILITY TESTING

MICROBIOLOGICAL TESTING

IMPURITY/DEGRADATION PRODUCT IDENTIFICATION

We manufacture, test and release both oral and sterile IMPs in the form of capsules and IV, including those containing cytotoxic and/or radiolabelled drugs. Find out more about our services here:

READ MORE

NON-CLINICAL AND CLINICAL BIOANALYSIS

METABOLITE IDENTIFICATION STUDIES

We provide robust data for drug development by producing, validating and applying state-of-the-art bioanalytical assays. Find out more about our offerings here:

READ MORE

CHROMATOGRAPHIC SERVICES

QC TESTING AND QP RELEASE

STABILITY TESTING

MICROBIOLOGICAL TESTING

LIQUID/SOLID STATE NMR

THERMAL ANALYSIS

Our analytical services provide and interpret high quality analytical, microbiological and materials science-based data. Find out more about our individual offerings here:

READ MORE

REGULATORY DOSSIERS

REGULATORY COMPLIANT ARCHIVING

POTENTIAL MUTAGENIC IMPURITY (GTI) ASSESSMENTS

CONSULTANCY

We provide one-to-one support to our clients and have the expertise to help with regulatory dossiers, regulatory compliant archiving and GTI assessments. Find out more about our offerings here:

READ MORE