Pharmaceutical Consultancy

End-to-End Compliance Solutions for the Pharma Industry

From documentation architecture to regulatory readiness, SPVT delivers precision consulting that keeps your facility audit-ready, compliant, and operationally sound.

Documentation

SOP Development & Optimisation

Documentation That Stands Up to Scrutiny

Standard Operating Procedures are the operational backbone of any regulated pharmaceutical facility. Poorly drafted or outdated SOPs are among the most common triggers for regulatory observations — and one of the most preventable.

SPVT's documentation specialists work directly with your operations and quality teams to develop SOPs that are technically precise, workflow-aligned, and written to the standard that CDSCO, WHO-GMP, and international inspectors expect.

What We Deliver

New SOP drafting across all functional areas (Production, QC, QA, Warehouse, Engineering)
Review and revision of existing SOPs against current regulatory expectations
SOP numbering, version control, and document management system design
Training record templates and competency assessment frameworks
IP · BP · USP

Pharmacopoeial Compliance

Aligning Your Formulations with Global Standards

Pharmacopoeial compliance is non-negotiable for any manufacturer targeting domestic or international markets. Whether you are working to Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), or United States Pharmacopeia (USP) standards, the requirements are exacting — and the consequences of non-compliance are severe.

SPVT's regulatory scientists conduct thorough gap assessments between your current specifications, test methods, and procedures against the applicable pharmacopoeial monographs, and guide your team through the remediation process.

What We Deliver

Pharmacopoeial gap analysis against IP, BP, and USP monographs
Specification review and update to align with current edition requirements
Test method review and harmonisation with pharmacopoeial procedures
Compliance roadmap with prioritised remediation actions
Process · Equipment · Analytical

Validation Services

Scientific Rigour Across Every Validation Domain

Validation is the documented evidence that your processes, equipment, and methods consistently produce results meeting predetermined specifications. It is a regulatory requirement — and a quality imperative.

SPVT's validation team brings structured methodology and deep regulatory knowledge to every engagement. We develop validation master plans, execute protocols, and compile reports that are built to withstand regulatory scrutiny.

What We Deliver

Process Validation — IQ, OQ, PQ protocols for manufacturing processes
Equipment Qualification — Installation, Operational, and Performance Qualification
Cleaning Validation — swab and rinse sampling, acceptance criteria, worst-case product selection
Analytical Method Validation — per ICH Q2(R1): specificity, linearity, accuracy, precision, robustness
CDSCO · WHO-GMP

Auditing & Regulatory Readiness

Prepare Your Facility Before the Inspector Arrives

Regulatory inspections — whether by CDSCO, WHO, or international agencies — are high-stakes events. Facilities that are caught unprepared face observations, warning letters, and in severe cases, import alerts or manufacturing suspensions.

SPVT's audit and regulatory readiness programme is designed to put your facility through the same rigour as a real inspection — before the real one happens. Our experienced auditors identify gaps, prioritise corrective actions, and work alongside your team to close them.

What We Deliver

Internal GMP audits against CDSCO Schedule M, WHO-GMP, and EU GMP standards
Gap analysis with risk-rated findings and a structured CAPA plan
Mock inspections simulating regulatory agency inspection methodology
Pre-inspection readiness review and front-room / back-room preparation

Ready to Strengthen Your Compliance Posture?

Speak directly with SPVT's consultancy team. We assess your current state, identify the highest-priority gaps, and build a practical roadmap to full regulatory readiness.

SCIENTIFICPVT

Precision. Compliance. Innovation.

Integrated pharmaceutical consultancy and scientific equipment manufacturing for the life sciences sector.

Contact

+91 8668706095info@scientificpvt.com
Andada, Bharuch, Gujarat, India

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Andada, Bharuch, Gujarat, India