BIOTECH & LIFE SCIENCES CONSULTING FIRM

Scientific & Technical Consulting Firm for Life Sciences

From early-stage biotechnology companies building their first laboratory capabilities to established pharmaceutical and diagnostics organizations expanding research and operations, Sharma Scientific provides focused scientific, quality and laboratory consulting. We support research method development, validation planning, quality systems, ISO internal auditing, laboratory equipment decisions and technical project execution.

Led by Ritu Sharma, an ISO 9001:2015 Certified Internal Auditor with hands-on experience in oncology R&D, molecular diagnostics QC, manufacturing, laboratory management and quality leadership.

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Direct founder access · Confidential initial discussion · Scope defined before engagement

ISO 9001:2015 certified internal auditorFounder credentialNearly a decade in laboratory settingsResearch, operations and quality systemsThree ways to engageAdvisory · Projects · Internal Audits

MEET THE FOUNDER

Ritu Sharma

Founder & CEO · ISO 9001:2015 Certified Internal Auditor

Ritu Sharma brings experience across Silicon Valley biotechnology, oncology R&D, molecular diagnostics quality control, manufacturing and laboratory quality operations. Her work spans cancer biology and CRISPR-related research, method development, ISO 9001 internal auditing, equipment qualification and technical procurement.

She built her career moving from hands-on bench science into quality systems leadership, internal auditing and cross-functional operations. Starting from assay development, cell-based research and CRISPR workflows, she grew into audit programs, CAPA governance and multi-organization quality leadership. That journey is what Sharma Scientific is built on. She founded the firm to bring that depth directly to life sciences organizations that need technically grounded, founder-led support.

ISO 9001:2015 certified internal auditorBiotech research & CRISPR backgroundWomen-owned business

Scientific foundationCancer biology & researchOperational experienceLab & quality systemsSharma ScientificFounder-led · Scientific & technical advisory

Have a scientific or laboratory project in mind?

Share your objective. We can discuss project fit, expected deliverables and the next step before any engagement.

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SERVICES

The expertise to move critical scientific and quality work forward.

Explore defined project support—from research methods, assay troubleshooting and scientific documentation to ISO audits, SOPs, vendor comparisons and equipment qualification planning. Work directly with the founder on an agreed scope and clear deliverables.

Biotechnology & Oncology R&D Support

Research methods · Assay development · Validation studies

For biotechnology and oncology teams that need focused scientific support to develop, evaluate or improve research methods and laboratory workflows.

Research method development, optimization and technical feasibility assessments
Oncology research support, cell-based assay development, target validation and CRISPR-related workflows
Assay troubleshooting, experimental design support and data-quality reviews
Research-use validation studies, method verification planning, study documentation and technical project coordination

Discuss a scientific project ↗

Quality Systems & ISO Internal Auditing

ISO 9001 internal audits · QMS · CAPA

For organizations that need an independent view of quality risks, stronger systems and audit-ready execution.

ISO 9001 internal audits, quality-system gap assessments and audit preparation
SOP and document-control development, training records and quality process mapping
Deviation, CAPA and corrective-action follow-up support
Manufacturing and laboratory QA/QC process reviews, including diagnostics-related documentation

Discuss an audit or quality project ↗

Laboratory Equipment, Procurement & Qualification

Equipment selection · Procurement · IQ/OQ/PQ

For laboratory teams evaluating an instrument purchase or implementation: translate technical requirements into comparable vendor proposals, assess options and plan qualification.

Translate testing and workflow needs into equipment requirements and vendor comparisons
Vendor quotation comparisons, supplier evaluation and procurement negotiation support
Installation, calibration, IQ/OQ/PQ and method-validation coordination
Instrument lifecycle documentation, training and implementation planning

Discuss equipment or validation ↗

Laboratory & Manufacturing Operations

Manufacturing quality · QC · Laboratory systems

For teams addressing operational bottlenecks, inconsistent practices or growing laboratory demands.

Laboratory and manufacturing-quality workflow reviews
Controlled procedures, personnel training and competency documentation
QC processes, reagent/material traceability and laboratory record improvements
LIMS and laboratory data workflow implementation support

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Scientific & Technical Advisory

Defined workstreams · Cross-functional coordination

For founders and scientific leaders who need a hands-on technical partner to turn a complex requirement into a scoped project.

Initial technical needs assessment and definition of deliverables
Coordination across research, QA/QC, operations, vendors and qualified specialist partners
Laboratory capability planning and technical decision support
Project-based support or an ongoing advisory arrangement

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Scope, applicable standards and auditor impartiality are confirmed before an engagement begins. Consulting does not guarantee certification or regulatory approval.

WHO WE HELP

Focused on life sciences. Experienced across technical industries.

We primarily support biotechnology, diagnostics, pharmaceutical research and life sciences laboratories. We also consider selected laboratory quality and operations projects in other science-driven industries when the scope matches our experience.

Our mission: help science-driven organizations strengthen quality, improve laboratory operations, and turn technical challenges into practical solutions.

01 / BIOTECH & LIFE SCIENCES

Biotech & life sciences

Biotechnology, oncology and diagnostics teams seeking research method support, laboratory quality systems, technical assessments and project execution.

02 / RESEARCH & TESTING

Research & testing laboratories

Research and testing laboratories developing methods, planning validation studies, qualifying equipment and improving technical operations.

03 / SCIENCE-DRIVEN INDUSTRIES

Manufacturing, energy & industrial labs

Quality and laboratory teams in industrial settings seeking scoped documentation, process-improvement, and internal-audit support.

OUR APPROACH

Clear scope. Practical execution.

A straightforward way to move your project forward.

01 / DISCUSS

Understand the need

Tell us what you need to accomplish and the challenges you're facing.

02 / PLAN

Define the work

Agree on the scope, deliverables, timeline and proposal.

03 / DELIVER

Get results

Complete the agreed work with clear communication and documented outcomes.

Engagement options

Ways to work with us

Project-Based Consulting

Focused scientific, quality or laboratory support with a defined scope and deliverables.

ISO 9001 Internal Auditing

Structured internal audits, quality-system assessments and actionable findings.

Ongoing Advisory

Continued technical and quality guidance aligned with your priorities.

Tell us what needs to get done.

Share the project objective, timing and support needed. You’ll speak directly with the founder to discuss fit, deliverables and a defined scope—without a full-time hiring commitment.

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Serving Clients Nationwide & InternationallyU.S.-based | Available for projects across the United States, Canada & internationally
Remote consulting, virtual collaboration & on-site project support

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Sharma Scientific LLC · Updated October 2026

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Sharma Scientific LLC · Updated October 2026

This website provides general information. Consulting work requires a separate written agreement defining scope, responsibilities, fees and deliverables. Website inquiries do not create a consulting engagement.

Sharma Scientific provides quality consulting and audit-readiness support and does not guarantee certification, regulatory approval or particular audit outcomes. Decisions remain with the relevant authorities and certification organizations.

Website content and branding belong to Sharma Scientific LLC. Third-party links are provided for convenience. Questions: [email protected].