Industries we Serve
Pharmaceutical
Bio-Pharmaceutical
Medical Devices
Cosmeceuticals
Food & Beverage
Our Mission
Our mission is to provide consulting, solutions, and services for the development of life science products that contribute to a safer, better world.
Our Vision
Simplify business challenges, maximize human potential, and optimize world health through
life science innovations.
WHY CHOOSE KATALYST
Experienced Scientific & Regulatory Team
A skilled team ensuring accurate, credible work across clinical research, regulatory affairs, data science, and safety.
End-to-End Integrated Services
Complete end-to-end support from planning to submission for smooth and efficient execution.
Quality & Compliance Driven Processes
We follow global standards (GCP, GLP, GMP, ICH) to ensure validated, audit-ready results.
Reliable, Accurate & On-Time Delivery
Strict timelines and validated workflows ensure consistent, dependable, and timely results.
OUR APPROACH
Our approach is built on precision, compliance, transparency, and scientific integrity. Every project follows a well-defined, 5-step methodology to ensure accuracy, safety, and regulatory acceptance.
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Requirement Understanding
We begin by understanding your study goals, regulatory expectations, and timelines. Our team evaluates feasibility, risks, and compliance needs. This helps define a clear project direction. A structured roadmap is created before planning begins.
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Study Planning & Design
We develop protocols, timelines, and essential documentation. Resources and responsibilities are clearly mapped. All plans follow GCP/GMP/ICH guidelines. This ensures a strong, compliant foundation for execution.
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Data Collection & Monitoring
Validated tools ensure accurate and reliable data capture. Continuous monitoring maintains protocol compliance. Issues are resolved promptly with proper documentation. The result is high-quality, audit-ready study data.
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Analysis & Quality Review
Experts perform statistical analysis and interpret insights. Quality checks verify accuracy at multiple levels. Outputs are validated to maintain integrity. Only fully reviewed data progresses to reporting.
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Reporting & Submission
We prepare study reports, summaries, and regulatory documents. Data listings, tables, and safety outputs are finalized. Submissions meet FDA, EMA, and CDSCO standards. Clients receive complete, compliant, professional deliverables.
OUR APPROACH
Our approach is built on precision, compliance, transparency, and scientific integrity. Every project follows a well-defined, 5-step methodology to ensure accuracy, safety, and regulatory acceptance.
We begin with a detailed discussion to understand your goals, study needs, regulatory requirements, timelines, and challenges.
Our team evaluates all technical and compliance aspects to design the right roadmap.
Includes:
Initial consultation & requirement gathering
Understanding study objectives
Regulatory expectations analysis
Risk assessment & feasibility check
After requirement clarity, we create a structured plan to guide execution.
Key activities:
Protocol development & study design
Timeline creation & milestone planning
Preparing essential documents (SOPs, CRFs, trackers)
Resource allocation & responsibility mapping
Compliance alignment with GCP/GMP/ICH guidelines
This ensures that the project starts with a strong foundation.
We implement the approved plan with strict adherence to quality and regulatory standards.
Process includes:
Accurate data collection using validated tools
Continuous data monitoring & issue resolution
Ensuring protocol compliance
Communication with stakeholders
Documentation of observations & deviations (if any)
Our monitoring ensures data accuracy and study integrity.
Once data is collected, our experts perform detailed analysis and multiple quality checks.
This step includes:
Statistical analysis & interpretation
Identifying trends, conclusions, and insights
Multi-level quality control (QC)
Validation of outputs for accuracy
Ensuring audit-readiness
Only thoroughly reviewed and validated data moves to the next stage.
We compile all results, prepare required documents, and support regulatory submissions.
Deliverables include:
Clinical Study Reports (CSR)
Safety reports & summaries
Data listings & tables
Regulatory documentation (FDA, EMA, CDSCO)
Final presentation to client & regulators
This ensures a complete, compliant, and professionally delivered outcome.
CERTIFICATIONS & COMPLIANCE
At Katalyst HLS, quality and compliance are the foundation of our operations. We follow globally recognized standards to ensure safety, accuracy, and regulatory acceptance across all scientific and clinical processes.
GCP — Good Clinical Practice
Ethical, precise, and human-led clinical study.
GCP — Good Clinical Practice
Ethical, precise, and human-led clinical study.
GCP — Good Clinical Practice
Ethical, precise, and human-led clinical study.
GCP — Good Clinical Practice
Ethical, precise, and human-led clinical study.
GCP — Good Clinical Practice
Ethical, precise, and human-led clinical study.
GCP — Good Clinical Practice
Ethical, precise, and human-led clinical study.
Scientific Areas Covering
Clinical Trial Operations
We support end-to-end clinical trial execution across Phase I–IV, ensuring ethical standards, smooth site management, patient safety, and high-quality study outcomes.
Data Management
Comprehensive data handling including eCRF/pCRF design, data entry, cleaning, validation, and secure database management for accurate and reliable study results.
Data Analyst
Statistical analysis and interpretation of clinical data using proven methodologies to deliver clear, science-driven insights for decision-making.
Medical Writing
Preparation of high-quality scientific and regulatory documents such as Clinical Study Reports (CSR), protocols, investigator brochures, and submission documents
Drug Safety & Pharmacovigilance
Monitoring, assessing, and reporting of adverse events (AE/SAE) to ensure patient safety and regulatory compliance throughout the product lifecycle.
Quality Control & Assurance
Rigorous QC/QA processes to maintain data integrity, ensure SOP compliance, and meet global GxP, GLP, and GMP quality standards.
Regulatory Affairs
End-to-end regulatory support, documentation, submissions, and guidance to meet international regulatory requirements and accelerate approvals.
Intellectual Property Rights
Strategic IPR support including patent search, documentation, and compliance guidance to protect innovation and manage risks effectively
Validations
Complete validation services for software, systems, equipment, and processes in compliance with GxP and industry standards to ensure accuracy and reliability.
Scientific Areas Covering
Clinical Trial Operations
Data Management
Data Analysis
Medical Writing
Drug Safety & Pharmacovigilance
Quality Control & Assurance
Regulatory Affairs
Intellectual Property Rights
Validations
Clinical Trial Operations
We support end-to-end clinical trial execution across Phase I–IV, ensuring ethical standards, smooth site management, patient safety, and high-quality study outcomes.
Data Management
Comprehensive data handling including eCRF/pCRF design, data entry, cleaning, validation, and secure database management for accurate and reliable study results.
Data Analysis
Statistical analysis and interpretation of clinical data using proven methodologies to deliver clear, science-driven insights for decision-making.
Medical Writing
Preparation of high-quality scientific and regulatory documents such as Clinical Study Reports (CSR), protocols, investigator brochures, and submission documents.
Drug Safety & Pharmacovigilance
Monitoring, assessing, and reporting of adverse events (AE/SAE) to ensure patient safety and regulatory compliance throughout the product lifecycle.
Quality Control & Assurance
Rigorous QC/QA processes to maintain data integrity, ensure SOP compliance, and meet global GxP, GLP, and GMP quality standards.
Regulatory Affairs
End-to-end regulatory support, documentation, submissions, and guidance to meet international regulatory requirements and accelerate approvals.
Intellectual Property Rights
Strategic IPR support including patent search, documentation, and compliance guidance to protect innovation and manage risks effectively
Validations
Complete validation services for software, systems, equipment, and processes in compliance with GxP and industry standards to ensure accuracy and reliability.
Trusted by Leading Life Science Organizations
Regulatory Affairs Manager, Biotech Firm
Their documentation quality, accuracy, and compliance knowledge stand out. The team delivered our study reports ahead of schedule without compromising on detail or regulatory requirements.
Biostatistics & Data Lead, Medical Device Company
Katalyst’s data management and statistical analysis support has been outstanding. Their validated processes and clear communication ensured a smooth and error-free study outcome.
Quality Assurance Director, Pharmaceutical Client
We were impressed by their professionalism and ethical approach. Every step—from planning to submission—was handled with precision, transparency, and a strong understanding of compliance.
Head of Medical & Scientific Affairs, Healthcare Organization
The Katalyst HLS team consistently demonstrated deep domain expertise and commitment to quality. Their proactive communication and precise documentation made our regulatory review process remarkably smooth.
Dr. Ananya Rao
Clinical Operations Lead, Global Pharma Company