QMS development, SOPs, internal audits and CAPA support for biotechnology, diagnostics, laboratories and regulated manufacturers.
Bring structure to your documentation, confidence to your team and clarity to your next audit.
Work directly with Ritu Sharma, Founder & CEO.
From emerging biotech companies to established laboratories and manufacturers, Sharma Scientific supports practical documentation, internal audits and quality improvements tailored to each organization’s needs.
Quality documentation, SOP development, training records and QMS foundations for growing research and development teams.
Quality-system gap assessments, controlled documentation and audit-readiness support within an agreed regulatory scope.
Practical SOPs, equipment and method records, training documentation and consistent laboratory workflows.
ISO 9001-oriented quality processes, internal audits, supplier documentation and corrective-action support.
Choose a focused project or ongoing support. Each engagement begins with an agreed scope, deliverables, timeline and fees.
Build the structure your team needs to work consistently and keep records organized.
Understand where you stand, document the gaps and put corrective actions into motion.
Get practical support for quality decisions, laboratory workflows and implementation.
Applicable standards and technical scope are confirmed before work begins.
We envision laboratories and growing organizations where quality systems support innovation, teams understand their processes and documentation reflects how the work is actually done.
Translate scientific experience and quality principles into clear procedures, useful records and actionable improvements. Meet each organization where it is, then help it move forward with a defined plan.
Quality systems work best when they fit the people, processes and science behind them.
Ritu's background in cancer biology, laboratory operations and quality management connects scientific work with practical systems.
Work directly with the founder from the first conversation through agreed deliverables and handover.
Prioritize the gaps that matter. Receive clear documentation, agreed milestones and guidance suited to your workflows.
Founder & CEO · Sharma Scientific LLC
The idea for Sharma Scientific began taking shape while Ritu Sharma was working in Silicon Valley's biotech ecosystem. Moving from cancer research and CRISPR gene engineering into quality control, R&D and quality assurance revealed a recurring challenge: strong science does not automatically create strong quality systems. Sharma Scientific was later founded in Buffalo, New York, to help close that gap.
Founded in Buffalo, New York, Sharma Scientific brings that perspective to QMS development, documentation, internal auditing and quality operations. Clients work directly with Ritu on focused projects or ongoing advisory engagements.
Ritu is a cancer biology researcher with experience in oncology and CRISPR gene engineering. She was a co-author of a cancer research abstract associated with the 2023 American Association for Cancer Research (AACR), a leading professional organization dedicated to advancing cancer research. Her scientific background informs a practical, science-first approach to quality systems.
Know what happens next, who is responsible and what your team will receive.
Start with a free 20-minute call. Discuss your quality gaps, priorities and target dates.
Review a proposal with deliverables, timeline, responsibilities and fees before the work begins.
Work through agreed milestones, practical documentation and a clear handover to your team.
Engagements can include gap assessment, process mapping, document hierarchy, SOP development, implementation guidance and internal audit preparation. The scope is tailored to your organization.
Yes. Sharma Scientific is based in Buffalo, New York and offers remote consulting for clients in the United States, Canada and internationally. Scope, applicable standards and location-specific requirements are confirmed before work begins. Any on-site work is discussed and agreed separately.
Potential support can include quality-system gap assessment and documentation readiness. Applicable standards, technical scope and required expertise are confirmed during consultation.
No. Sharma Scientific provides consulting and audit-readiness support. Certification and regulatory decisions are made by the relevant certification organizations and authorities.
Fees depend on the scope, deliverables and timeline. After the initial consultation, you receive a proposal for a defined project or ongoing advisory arrangement.
Tell us about your quality challenge and your timeline. Start with a free 20-minute consultation to discuss fit and next steps.
ritu@sharmascientific.com ↗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: ritu@sharmascientific.com.