Critical quality attributes

The OmniRAM’s set of design and features reflects users’ critical requirements: processing speed, mixing power, and optimal parameter development to mid-scale pilot and production RAM machines. Its integrated touch-screen operating system enables recipe development and data management. Optional processing ...

Fundamental to your biopharmaceutical chemistry, manufacturing and controls (CMC) development, you will need detailed analytical characterisation data to satisfy regulatory requirements. Our experts strategically deploy orthogonal protein analysis approaches that address key molecular and biological charac...

Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing. We have powerfull compaction simulation tools ( STYL'One evolution) allowing to derisk and fasten scale-up steps. 
Our capabilities :...

Our Quality Assurance Services focus on delivering top-quality products by tailoring solutions to meet your unique needs. Whether it’s through expert manual testing, developing robust automation test frameworks, or consulting on industry-standard testing processes, we ensure that every solution aligns with...

Fully automated system to determine the quality of Auto Injectors.

 
- Pen Injector Batch Release – Sample Test

    - Semi-automatic system:

    - Manual loading / unloading

    - Fully automated inspection q...

Biopharmaceutical Characterization & Testing: By leveraging expert insight into a biologic’s structure, physicochemical properties, potency, and impurity profile, we help you achieve critical development milestones with confidence.

A range of expertise is available, includin...

Gene Therapy Characterization & Release Testing: We support CMC requirements for IND applications and commercial release through expert analysis, stability testing, and comprehensive characterization of gene therapies. We provide method development and validation to meet your milestone and regulat...

GMP & CMC Laboratory Services: We deliver regulatory-driven, phase-appropriate laboratory support for CMC programs - from preformulation through formulation to product release - ensuring compliance and quality at every stage. Among our capabilities are centres of excellence for method development and ...

mRNA Characterization & Analysis: We support vaccine and therapeutic development through detailed characterization and analysis of mRNA, including assessments of clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug pr...

Analytical Development for Oligonucleotides: For oligo-based drugs, our services span from GLP bioanalysis to GLP/cGMP characterization, supporting development with robust analytical expertise. We support product development, from quality control testing of amidite starting materials and early stage produc...

Vaccine Development Support: Our vaccine development experts offer a comprehensive suite of services, including analysis, delivery support, quality control of process and batch release samples, and stability studies. We support the development of a range of vaccines, including mRNA, protein, glycoprot...

Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) which can support your product development from an early stage and across the lifecycle of your drug product including method development / validation and di...

Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity l...

At A-Squared Pharma, we partner with pharma and biotech companies to simplify EU market entry for investigational and commercial medicines. Our HPRA-authorised services include drug importation, QC testing, QP release, and audit support. We combine speed, compliance, and scientific rigour to...

Our HPRA-authorized services include drug importation, QC testing, QP release, and audit support. We combine speed, compliance, and scientific rigor to deliver tailored solutions that reduce complexity, maintain quality, and help clients achieve their goals faster—whether for investigational...

The Walk-In Cooling Cabinets / cold rooms are designed according to ICH guidelines, WHO, MCA and USFDA requirements to maintain uniform conditions. They are superior in airflow distribution, temperature control technology, cabinet construction and are manufactured as per cGMP regulations.
Biggest Walk...