Our Services

We develop and validate robust analytical methods to ensure safety, efficacy, and consistency of pharmaceutical products, aligned with ICH Q2(R1), USP, EP, and FDA guidelines. Our phase-appropriate strategies span clinical through commercial stages.

• Phase Appropriate Method Development – Tailored methods supporting clinical to commercial development.
• Chromatographic & Spectroscopic Techniques – HPLC, UPLC, GC, UV-Vis, FT-IR, NMR, and Raman for comprehensive characterization.
• Regulatory Compliant Validations – Ensuring accuracy, precision, linearity, robustness, and global regulatory readiness.
• Automation & High-Throughput Screening – AI-driven workflows and liquid handling automation for reproducibility and efficiency.
• Stability Indicating Methods – Forced degradation studies to reveal degradation pathways.

Comprehensive analytical support for biologics including mAbs, fusion proteins, and bispecifics to ensure structural integrity and batch consistency.

• Glycosylation Profiling – LC-MS, CE, MALDI-TOF MS for structural glycan analysis.
• Aggregation Studies – Using SEC, DLS, and MFI to characterize aggregation and particles.
• Binding Assays – ELISA, SPR (Biacore), and cell-based assays for potency evaluation.
• Host Cell Protein (HCP) & DNA – Quantitation using ELISA and qPCR.
• Higher Order Structure (HOS) – CD, FT-IR, fluorescence spectroscopy for folding & structure.

Advanced techniques for structure-function analysis of proteins and peptides, ensuring stability and efficacy.

• Molecular Weight & Sequence – LC-MS/MS, MALDI-TOF, Edman sequencing.
• Post-Translational Modifications – Analysis of phosphorylation, glycosylation, acetylation.
• Disulfide Bond Mapping – LC-MS/MS and enzymatic digestion for cysteine confirmation.
• Isoelectric Focusing & Charge Variants – cIEF, IEX for charge heterogeneity.
• Stability & Aggregation Studies – Stress testing under pH, temperature, and agitation.

We provide impurity detection and profiling using sensitive MS-based technologies for ICH Q3A/B/C compliance.

• Genotoxic Impurity Screening – LC-MS/MS, GC-MS, HRMS for trace level mutagens.
• Elemental Impurities – ICP-MS and ICP-OES for toxic metals (As, Cd, Hg, Pb).
• Residual Solvents – GC-HS for Class 1–3 solvents per ICH Q3C.
• Nitrosamine Testing – Specialized MS methods to quantify NDMA and related compounds.

We assess degradation pathways and long-term product stability to support regulatory submissions and shelf-life prediction.

• Forced Degradation – Testing oxidation, photolysis, hydrolysis under stress.
• Accelerated & Long-Term Stability – Per ICH Q1A (R2) for shelf-life and packaging suitability.
• Photostability Testing – Evaluating light-induced degradation per ICH Q1B.
• Degradation Profiling – LC-MS, NMR, chromatography for impurity identification.

Thorough assessments of container-closure systems and manufacturing components to ensure patient safety and regulatory compliance.

• Targeted E&L Screening – Using GC-MS, LC-MS, ICP-MS under controlled conditions.
• Risk Assessment – Simulated drug-contact scenarios using stability studies.
• Regulatory Compliance – Supporting USP <661> & <1664>, FDA, EMA submissions.

We deliver complete testing services to ensure nitrosamine levels are within globally accepted limits for APIs, excipients, and drug products.

• Regulatory Approved Methods – LC-MS/MS, GC-MS, HRMS ensuring compliance with FDA, EMA.
• Root Cause Analysis – Identifying nitrosamine sources in raw materials and synthesis.
• Batch Release & Surveillance – Routine testing across manufacturing lifecycle.

Ensuring predictable process performance during scale-up and scale-down is critical to maintaining product quality, yield, and regulatory compliance. We implement Design of Experiments (DoE) and Quality by Design (QbD) principles to establish a scientifically robust and scalable manufacturing process.

• QbD-Based Process Development – Identifying CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) to ensure process reproducibility and robustness.
• Scale-Up Studies for Commercial Readiness – Optimizing equipment selection, batch size transitions, and process reproducibility for GMP production.
• Scale-Down Models for Process Validation – Developing lab-scale and pilot-scale models to simulate commercial manufacturing conditions, de-risking large-scale production.
• Tech Transfer Support – Ensuring seamless technology transfer from development to clinical and commercial manufacturing.
• Process Analytical Technology (PAT) Integration – Real-time monitoring and control to minimize process variability and ensure quality.

The development of biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, requires precision process control to maintain purity, potency, and consistency. Our upstream and downstream process expertise enables high-yield, high-quality production of biologic therapeutics.

• Upstream Cell Culture Optimization – Developing high-density fed-batch and perfusion culture systems to maximize yield and productivity.
• Downstream Purification Strategies – Implementing chromatographic techniques (Protein A, ion exchange, size exclusion) and filtration technologies for high-purity biologics.
• Media & Feed Strategy Development – Customizing nutrient formulations and metabolic profiling to enhance cell growth and protein expression.
• Aggregation & Stability Optimization – Utilizing high-throughput analytics and forced degradation studies to ensure product stability throughout development.
• Viral Clearance & Contaminant Removal – Designing scalable viral filtration and inactivation processes to meet global regulatory requirements.

Artificial Intelligence (AI) and machine learning-driven process optimization provide predictive insights and adaptive control strategies to refine manufacturing parameters, reduce variability, and improve efficiency. These approaches de-risk manufacturing scale-up and drive cost-effective solutions for biotech firms and specialty pharma.

• Predictive Analytics for Process Optimization – Utilizing AI algorithms to identify optimal operating conditions and real-time corrective actions.
• Multivariate Process Control (MVPC) – Implementing AI-based modeling to ensure process reproducibility and batch consistency.
• Continuous Learning Systems – Adaptive AI platforms that refine manufacturing parameters over time, improving yield and efficiency.
• Cost Reduction & Resource Optimization – AI-driven waste minimization and energy-efficient process design, leading to cost savings and improved sustainability.
• Data-Driven Process Troubleshooting – Early detection of process deviations through real-time AI-assisted monitoring, reducing batch failures and regulatory risk.

Continuous manufacturing (CM) is revolutionizing pharmaceutical production, offering higher process reliability, reduced production time, and increased product quality. Our team develops next-generation manufacturing strategies incorporating inline quality control and real-time process monitoring to ensure seamless, high-throughput production.

• Integrated PAT & Real-Time Release Testing (RTRT) – Ensuring continuous quality assurance with inline analytics and AI-driven process monitoring.
• Hybrid Batch & Continuous Manufacturing Models – Combining batch and CM approaches for flexible, scalable production solutions.
• Process Intensification Strategies – Optimizing bioprocessing conditions to reduce costs, improve yield, and accelerate time to market.
• Regulatory Alignment for CM Approvals – Assisting with FDA Emerging Technology Program (ETP) and ICH Q13 compliance to facilitate continuous manufacturing adoption.
• Automation & Digital Twin Integration – Utilizing digital twins for real-time process simulation and risk assessment.

Pilot-scale process refinement is critical for transitioning from laboratory-scale development to full-scale production. We specialize in pilot plant-based process validation, de-risking large-scale manufacturing while ensuring regulatory compliance and commercial viability.

• Pilot Plant Feasibility Studies – Evaluating process robustness, batch reproducibility, and technology transfer readiness.
• GMP Pilot Production Runs – Conducting small-scale clinical batch manufacturing to assess process scalability and operational efficiency.
• Tech Transfer Readiness – Supporting seamless scale-up from pilot to commercial production, minimizing process variability and production failures.
• Process Safety & Risk Assessments – Identifying scale-up risks, thermal safety issues, and process bottlenecks before transitioning to full-scale production.
• Regulatory Compliance Support – Ensuring that pilot-scale processes meet cGMP, FDA, EMA, and ICH guidelines, paving the way for seamless commercialization.

A well-defined control strategy is essential to ensure process robustness, product consistency, and regulatory compliance. We establish comprehensive definitions of CPPs, CQAs, and risk-based control strategies to support accelerated development and commercialization of pharmaceutical products.

• Risk-Based CPP & CQA Identification – Utilizing DoE and multivariate analysis to identify critical process variables impacting product quality.
• Real-Time Process Monitoring & Control – Implementing PAT-enabled monitoring to track batch-to-batch consistency and reduce process variability.
• Adaptive Control Strategies – AI-driven adaptive process control models to predict and correct deviations before impacting product quality.
• Regulatory Alignment with QbD Principles – Ensuring compliance with ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System).
• Tech Transfer & Commercial Readiness – Finalizing process validation strategies, preparing CMC submission data, and ensuring regulatory audit readiness.

The production of clinical trial materials (CTMs) under cGMP conditions is essential for early-phase clinical studies, ensuring quality, safety, and regulatory compliance. We provide flexible, scalable small-batch manufacturing tailored to the needs of biotech firms and specialty pharmaceutical developers.

• GMP-Compliant CTM Production – Manufacturing solid dosage forms, injectables, biologics, and specialty formulations under strict regulatory guidelines.
• QbD-Driven Process Control – Implementing real-time quality risk management, process optimization, and in-process monitoring to ensure product consistency.
• Clinical Batch Manufacturing for Phase I-III Trials – Producing early-phase clinical trial supplies with seamless scalability for late-stage and commercial production.
• Sterile & Aseptic Manufacturing Support – Ensuring microbial control, sterility assurance, and contamination prevention in parenteral and biologic formulations.
• On-Demand, Flexible Batch Production – Rapid turnaround times and adaptive manufacturing to meet tight clinical trial deadlines.

Successful formulation development begins with a comprehensive understanding of API characteristics and stability. Our pre-formulation screening services provide detailed physicochemical characterization to define optimal formulation and process strategies, de-risking clinical and commercial development.

• Physicochemical API Characterization – Evaluating solubility, polymorphism, hygroscopicity, and stability profiles to identify formulation challenges early.
• Excipient Compatibility Studies – Assessing potential API-excipient interactions to select the most stable and bioavailable formulation excipients.
• Solid-State & Polymorph Screening – Identifying the most thermodynamically stable polymorphic form for long-term drug stability and performance.
• Lipid, Nanoparticle & Solubility Enhancement Strategies – Customizing lipid-based systems, amorphous solid dispersions, and nanoformulations to improve drug bioavailability.
• Process Feasibility Assessments – Conducting early-stage manufacturing feasibility testing to streamline scale-up and commercialization.

Regulatory submission success relies on comprehensive CMC documentation, stability reports, and batch record accuracy. We provide fully compliant, regulatory-ready documentation to support IND/IMPD submissions, ensuring accelerated approvals for biotech startups and specialty pharma.

• CMC (Chemistry, Manufacturing & Controls) Documentation – Preparing GMP-compliant regulatory packages for FDA, EMA, and PMDA submissions.
• IND/IMPD Submission Support – Providing batch records, process validation reports, and analytical data to facilitate early-stage regulatory approvals.
• Stability Studies & ICH Compliance Reports – Conducting real-time and accelerated stability testing to define shelf-life, degradation pathways, and formulation robustness.
• Batch Release Testing & Quality Control Reports – Ensuring compliance with cGMP regulations, supporting clinical trial initiation and product commercialization.
• Regulatory Filing & Gap Analysis – Reviewing documentation for completeness, accuracy, and alignment with global regulatory expectations.

A well-executed technology transfer ensures that product knowledge, process parameters, analytical methods, and quality control strategies are accurately and efficiently transferred to CMOs (Contract Manufacturing Organizations) and CDMOs (Contract Development and Manufacturing Organizations). We develop structured technology transfer packages to enable successful scale-up and commercialization.

• Comprehensive Technology Transfer Packages – Defining process parameters, raw material specifications, analytical methods, and control strategies to ensure a seamless transition from R&D to GMP production.
• Risk Mitigation Strategies – Identifying and addressing potential scale-up challenges using FMEA (Failure Modes and Effects Analysis) and risk-based control plans.
• Knowledge Transfer & Training – Conducting on-site and virtual training for manufacturing teams, process engineers, and QC analysts to ensure process consistency.
• Regulatory Compliance & Documentation – Providing detailed CMC documentation, batch records, and validation reports aligned with FDA, EMA, and ICH guidelines.
• Tech Transfer Gap Analysis & Optimization – Evaluating process gaps and implementing corrective actions to streamline scale-up and commercial readiness.

A QbD-driven, DoE-based validation approach ensures that process variability is minimized, product quality is optimized, and regulatory compliance is met. Our team employs advanced statistical models and real-time monitoring techniques to validate processes efficiently and cost-effectively.

• Risk-Based Validation Strategies – Using FMEA and risk assessment tools to identify high-impact process variables and optimize manufacturing conditions.
• Multivariate Statistical Analysis & DoE Optimization – Implementing DoE methodologies to determine CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) for robust process control.
• Stage 1-3 Process Validation (ICH Q8, Q9, Q10 Compliance) – Executing prospective, concurrent, and retrospective validation studies to ensure regulatory alignment.
• Real-Time Process Monitoring & Control – Utilizing Process Analytical Technology (PAT) and AI-driven predictive models to enhance process reproducibility and product quality.
• Post-Validation Continuous Improvement – Implementing data-driven process optimization strategies to improve long-term manufacturing efficiency and compliance.

A well-characterized and qualified manufacturing process requires precise equipment selection, qualification protocols, and process scalability studies. We support biotech firms and specialty pharma in validating equipment, ensuring process scalability, and facilitating smooth regulatory approvals.

• IQ/OQ/PQ (Installation, Operational & Performance Qualification) – Developing comprehensive qualification protocols for manufacturing, analytical, and packaging equipment.
• Scalability Assessments & Engineering Runs – Evaluating equipment compatibility, process feasibility, and batch consistency before full-scale manufacturing.
• GMP Compliance & Regulatory Readiness – Ensuring that equipment qualification and process validation meet FDA, EMA, and ICH Q7/Q9/Q10 guidelines.
• Process Scale-Up & Manufacturing Efficiency Optimization – Implementing AI-driven process modeling and pilot-scale validation studies to ensure seamless transition to commercial production.
• Continuous Manufacturing Integration – Supporting the adoption of next-generation manufacturing technologies, inline PAT, and automation strategies for cost-efficient, scalable production.

Preparation of Module 3 documentation including stability data, method validation, and manufacturing process details required for NDA/BLA submissions, ensuring specialty pharma meets regulatory requirements.

Establishing post-approval change control strategies that minimize regulatory burden and ensure consistent product quality, critical for specialty pharmaceutical firms.

Strategic consulting to navigate regional and global regulatory landscapes, ensuring smooth product approvals and market expansion for biotech startups and specialty pharma.