Consulting & Technical Advisory
Specialized consulting, technical advisory, and project management for life science facilities, laboratories, and regulatory systems.
Somru BioScience provides specialized consulting, technical advisory, and project management services for governments, development agencies, pharmaceutical manufacturers, biotechnology companies, contract research organizations (CROs), and regulatory authorities.
Drawing upon our expertise in regulated laboratory operations, bioanalytical sciences, quality systems, clinical research, AI-enabled analytics, and biopharmaceutical development, we help organizations design, build, validate, and operate facilities that meet international regulatory standards.
Our Consulting Expertise
Biopharmaceutical Facility Planning & Design
We support the development of:
- Vaccine manufacturing facilities
- Biosimilar and biologics manufacturing plants
- Bioanalytical laboratories
- National drug control laboratories
- Clinical trial laboratories
- Diagnostic kit manufacturing facilities
- Research and development centers
- GMP and GLP training centers
Our team provides guidance from concept design through operational readiness.
Regulatory & Quality Systems Advisory
Our experts assist organizations in achieving compliance with:
- WHO GMP
- WHO GLP
- OECD GLP
- ISO 17025
- ISO 15189
- GCLP
- FDA 21 CFR Part 11
- ICH Guidelines
- PIC/S GMP
- National Regulatory Authority (NRA) strengthening initiatives
Services include:
- Gap assessments
- Regulatory readiness programs
- SOP development
- Quality Management System (QMS) implementation
- Data integrity assessments
- Inspection readiness
- Validation master planning
Engineering, Procurement & Construction (EPC) Advisory
Somru supports clients through all phases of major life science infrastructure projects:
- User Requirement Specifications (URS)
- Facility programming and master planning
- Procurement strategy development
- Technical specification preparation
- Bid document preparation and evaluation
- Vendor qualification
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Commissioning and qualification oversight
- Construction monitoring and quality review
Laboratory Establishment & Validation
We provide technical support for:
- National Drug Control Laboratories
- Vaccine testing laboratories
- Biologics testing laboratories
- Biosafety laboratories
- Clinical research laboratories
- Central laboratories
- Diagnostic development laboratories
Services include:
- Laboratory workflow design
- Equipment selection and qualification
- Method transfer
- Method validation
- Laboratory Information Management Systems (LIMS)
- Laboratory automation
- Operational readiness assessments
Technology Transfer & Manufacturing Readiness
Our specialists help organizations establish:
- Fill-finish operations
- Biosimilar manufacturing programs
- Diagnostic manufacturing programs
- Analytical transfer programs
- Process transfer and scale-up
- Training and workforce development frameworks
Project Management & Independent Oversight
Somru provides independent project oversight for complex life science projects, including:
- Project Performance Monitoring Systems (PPMS)
- Risk management
- Schedule and budget monitoring
- Contractor performance review
- Quality assurance and quality control oversight
- Environmental, Health & Safety (EHS) compliance review
- Operational readiness assessments
Digital Transformation & AI-Enabled Quality Systems
Leveraging Somru's proprietary digital expertise, we assist clients with:
- Laboratory digitalization
- Electronic Quality Management Systems (eQMS)
- LIMS implementation
- AI-assisted process monitoring
- Data analytics and dashboards
- Predictive quality monitoring
- Regulatory data management solutions
Why Somru BioScience
Global Expertise
Experience supporting pharmaceutical, biotechnology, diagnostics, and clinical research programs across North America, Europe, Asia, and the Middle East.
Regulatory Excellence
Deep expertise in GMP, GLP, GCLP, bioanalytical validation, immunogenicity testing, biomarker analysis, and quality systems.
Integrated Scientific Team
Multidisciplinary experts in:
- Bioanalysis
- Immunology
- Clinical research
- Regulatory affairs
- Quality assurance
- Laboratory operations
- Data science and AI
Practical Implementation Focus
We combine scientific knowledge, operational experience, and project execution expertise to help clients move efficiently from concept to compliant operation.
Contact Us
Whether you are planning a new facility, strengthening regulatory systems, implementing quality standards, or preparing for international accreditation, Somru BioScience can provide the scientific, technical, and operational expertise needed to achieve your goals.
info@somrubioscience.com