RMA delivers high-quality analytical testing solutions designed to support pharmaceutical and life science products from early development through commercial supply. Our laboratories operate in a GMP-compliant environment and generate defensible analytical data suitable for regulatory submissions, quality decisions, and ongoing product support.
By combining strong scientific expertise with responsive client engagement, RMA offers both standardized pharmacopeial testing and tailored analytical solutions for Raw Materials and Finished Products to address complex product and regulatory requirements.
Pharmacopeial (Compendial) Testing
RMA performs analytical testing in accordance with recognized global pharmacopeias to support material qualification, batch disposition, and regulatory compliance.
- Testing aligned with USP, EP, JP, BP, ChP, ACS, and related standards
- Identity confirmation and assessment of critical quality attributes
- Purity, strength, and specification compliance testing
- Release and stability testing to support regulatory filings
Non-Pharmacopeial & Customized Analytical Methods
Support for analytical methods that fall outside established compendial frameworks.
- Execution of proprietary, client-supplied, and legacy methods
- Customized analytical approaches based on product-specific needs
Method Development, Validation & Transfer
End-to-end analytical method lifecycle support to ensure methods are scientifically sound, reproducible, and fit for their intended purpose.
- Feasibility assessments and method development for APIs, excipients, raw materials, and finished dosage forms
- Analytical method validation performed in alignment with ICH Q2(R1)/(R2) expectations
- Method verification to confirm suitability of compendial and non-compendial methods within RMA laboratories
- Method transfer and co-validation activities from client or third-party sites
- Forced degradation and stability-indicating studies to support impurity characterization
Raw Materials Analysis
Analytical testing to confirm the identity, quality, and suitability of incoming materials for pharmaceutical manufacturing.
- Material identification using FTIR, UV-Vis, HPLC, and GC techniques
- Physicochemical characterization includes pH, moisture, loss on drying, and residue on ignition
- Residual solvent determination
- Elemental impurity and trace metal analysis
- Particle size and material property assessment
Finished Product Testing
Analytical support for a broad range of pharmaceutical dosage forms.
- Quantitative assay and content uniformity testing
- Dissolution and disintegration performance testing
- Impurity and degradation assessment
- Physical and functional testing to support release and stability programs
Stability Testing Programs
Comprehensive stability testing services designed to support product development, registration, and ongoing commercial supply.
- Long-term, intermediate, and accelerated stability studies per ICH guidance
- Photostability evaluations (ICH Q1B)
- In-use and transportation stability studies
- Stability protocol design, data evaluation, and trend analysis
Elemental & Trace Impurity Analysis
High-sensitivity testing for inorganic impurities and trace-level contaminants.
- Elemental impurity testing aligned with ICH Q3D
- Trace and heavy metal analysis
- Catalyst residue testing
- Analytical support for cleaning validation programs
Regulatory & Quality Support
Analytical services delivered with a strong emphasis on data integrity, documentation quality, and inspection readiness.
- GMP-compliant testing and controlled documentation
- Scientifically sound, regulatory-ready analytical reports
- Investigative testing and root-cause analysis
- Audit and regulatory inspection support
- Analytical support for IND, NDA, ANDA, and DMF submissions
Why RMA
- Quality-driven, GMP-compliant laboratory operations
- Broad analytical expertise spanning pharmacopeial and customized testing
- Flexible engagement models tailored to client needs
- Transparent communication and reliable turnaround timelines
- Scalable analytical support across the product lifecycle
