Founder-led quality and compliance support for biotech, life sciences, laboratories and regulated organizations.
Nearly a decade of hands-on laboratory and quality experience, translated into practical guidance, delivered projects and independent internal audit support.
Work directly with Ritu Sharma, founder and ISO 9001:2015 certified internal auditor.
Clear services, defined outcomes, and direct access to the person doing the work.
Practical guidance for quality strategy, regulatory readiness, laboratory operations and systems decisions.
Explore advisory ↗02 / PROJECT EXECUTIONScoped implementation work: QMS, SOPs, document control, CAPA workflows and laboratory process improvements.
Explore projects ↗03 / INTERNAL AUDITINGObjective system reviews, documented findings, prioritized gaps and corrective-action follow-up.
Explore audits ↗Whether you are organizing your first quality system, resolving documentation gaps or preparing for an internal audit, start with the support your operation actually needs.
Teams that need clear procedures, controlled documentation and quality processes as their organization grows.
Laboratories strengthening SOPs, equipment records, training and consistent day-to-day workflows.
Organizations addressing ISO 9001 readiness, internal audits, supplier quality and corrective actions.
Choose strategic guidance, a hands-on delivery project, or a defined internal audit. Every engagement begins with a clear scope, deliverables and timeline.
Get a scientific quality partner for decisions, priorities and ongoing support.
Move from recommendations to completed, usable quality deliverables.
Identify gaps through structured reviews and prepare teams for the next audit.
Scope, applicable standards and auditor impartiality are confirmed before an engagement begins. Consulting does not guarantee certification or regulatory approval.
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
Sharma Scientific grew from Ritu's work in the Bay Area biotech ecosystem and nearly a decade spent in laboratory settings. Experience across cancer biology, gene engineering, laboratory operations and quality management revealed a recurring need: strong science needs equally strong systems.
Founded in Buffalo, New York, Sharma Scientific offers three ways to engage: quality advisory, hands-on project delivery and internal auditing. Ritu leads every engagement directly, bringing a bench-level understanding of the work behind the documentation.
View the one-page capability statement ↗
Background and credentials describe Ritu’s experience before founding Sharma Scientific in 2026; they are not presented as completed Sharma Scientific client engagements. Supporting credentials are available on request.
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.
Internal audits must be objective and impartial. We evaluate potential conflicts before accepting audit work; where independence would be compromised, the audit scope is adjusted or an independent auditor is recommended.
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 ↗Recruiters and staffing partners: Sharma Scientific welcomes introductions for scoped quality projects, interim support and internal auditing engagements. Please include the client industry, scope and expected timeline.
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.