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PHARMA CONSULTANCY

Ecoverix Solutions Pvt. Ltd. — Empowering Pharmaceutical Excellence

At Ecoverix Solutions Pvt. Ltd., we partner with the pharmaceutical and life sciences industry to deliver integrated, compliant, and innovative consultancy solutions.
Our services span the entire pharmaceutical value chain — from clinical development to manufacturing excellence — ensuring regulatory compliance, quality assurance, and operational optimization.

  1. cGMP, GCP Audit & Quality Management System (QMS) Services

Ecoverix offers end-to-end GxP Audit and QMS consultancy to help organizations achieve and sustain regulatory excellence.
Our capabilities include:

  • Comprehensive gap assessments, documentation, and SOP standardization
  • Internal and supplier audits for cGMP, GLP, and GCP compliance
  • CAPA planning, deviation management, and risk-based quality improvement
  • QMS implementation aligned with WHO, EU, USFDA, and CDSCO guidelines

     2. Clinical Development Solutions

We provide strategic and operational support across all stages of clinical trials, ensuring efficiency, ethics, and regulatory compliance.
Our services include:

  • Clinical trial design and protocol review
  • Site and investigator selection, training, and monitoring
  • Regulatory documentation and submission support
  • Oversight of data integrity and clinical trial management
  1. Clinical Data Management (CDM)

Our CDM professionals ensure accuracy, consistency, and compliance throughout the clinical data lifecycle.
Key offerings:

  • Database design, setup, and validation
  • Data entry, cleaning, and discrepancy resolution
  • Compliance with 21 CFR Part 11, GCP, and GDPR
    • Statistical programming and data lock activities
    1. Pharmacovigilance (PV) Services

    Ecoverix enables organizations to build and maintain robust drug safety systems that comply with global regulations.
    Core services:

    • ICSR (Individual Case Safety Report) processing
    • Aggregate reporting (PBRER, PSUR, PADER)
    • Signal detection and risk management planning
    • PV SOP development, QMS integration, and audit readiness
    1. Project Management Solutions

    We provide strategic oversight and execution support for complex pharmaceutical projects.
    Our focus areas include:

    • Project planning, scheduling, and milestone tracking
    • Cross-functional coordination and vendor management
    • Risk assessment and resource optimization
    • Project governance and performance frameworks
    1. Pharmaceutical Utility Management

    We help facilities achieve safe, efficient, and sustainable utility operations.
    Services include:

    • Utility system audits (HVAC, water, steam, compressed air, etc.)
    • Qualification and validation documentation
    • Energy and water efficiency assessments
    • Integration with ISO 50001 and ESG frameworks
    1. Automation & Digital Transformation

    Embrace Industry 4.0 and enhance productivity with smart automation and digital systems.
    Our expertise covers:

    • Automation of QMS and batch documentation processes
    • Real-time data dashboards and performance monitoring
    • AI-powered deviation and trend analysis
    • Support for digital validation and paperless compliance
    1. ISO Certification Consultancy

    We assist organizations in implementing and certifying management systems aligned with international standards:

    • ISO 9001 — Quality Management System
    • ISO 27001 — Information Security Management
    • ISO 22301 — Business Continuity Management
    • ISO 14001 — Environmental Management
    • ISO 45001 — Occupational Health & Safety
    • ISO 50001 — Energy Management

    Why Choose Ecoverix Solutions?

    ✅ Deep expertise in pharmaceutical quality and regulatory compliance
    ✅ Cross-functional team of auditors, technologists, and industry experts
    ✅ Proven success in audit preparation and certification readiness
    ✅ Strong commitment to sustainability, data integrity, and operational excellence

    📧 Email: avneesh@ecoverix.com

FAQs:

Top Questions for Pharmaceutical Consultancy

  1. What services does a pharmaceutical consultancy offer to Indian drug manufacturers?
  2. How to choose a reliable pharmaceutical consultant in India?
  3. What is the cost of hiring pharma consultancy services in India?
  4. How can pharma consultancy help with regulatory approvals (FDA / CDSCO) in India?
  5. What documentation does pharma consultancy help prepare (SOPs, validation, regulatory)?
  6. How can pharma consultancy help reduce manufacturing costs?
  7. What are the timelines for consultancy engagements (plant setup, compliance) in India?
  8. Can pharma consultancy help with export / international market registration?
  9. What qualifications / experience should a good pharma consultant have?
  10. How do pharma consultancies differ from internal regulatory or QA teams?

🧪 Top Questions for Pharma Quality Consultancy

  1. What is pharma quality consultancy and when is it needed?
  2. How can pharma quality consultants improve compliance with GMP standards?
  3. What is the process of gap analysis in pharma quality systems?
  4. What are common quality issues in pharma manufacturing, and how a consultant fixes them?
  5. How long does it take to implement a quality management system (QMS) in an Indian pharma plant?
  6. What is the cost of pharma quality consultancy in India?
  7. How to select a quality consultant who understands local & international standards (e.g., ICH, WHO, FDA)?
  8. How can quality consultancy help with audits (internal, third-party, regulatory)?
  9. What are pharma quality documentation deliverables (e.g. SOPs, BMR, BPR)?
  10. How does pharma quality consultancy support product release and batch record review?

⚙️ Top Questions for Pharma Utility Consultancy

  1. What is pharma utility consultancy / pharma utility systems?
  2. How can pharma utility consultants help with HVAC, Water for Injection (WFI), boilers, chilled water, steam systems etc.?
  3. How to ensure utility systems comply with regulatory & validation requirements in pharma plants?
  4. What are the audit / validation protocols for pharma utility systems?
  5. How much time / cost is involved in validating a utility system in India?
  6. What are common utility system issues faced by pharma factories in India?
  7. How can utility consultancy reduce utility maintenance / running costs?
  8. How to qualify utility equipment suppliers & manage utility documentation?
  9. What is the role of cleaning validation, calibration, monitoring for utility systems?
  10. How often are utility systems inspected / re-validated/audited under GMP?

🧬 Top Questions for Clinical Research

  1. What is clinical research certification / training in India?
  2. What are the regulatory requirements for clinical trials in India (e.g. ICMR / CDSCO / GCP)?
  3. What roles are available after doing clinical research training?
  4. How long does clinical research training take, and what is the cost in India?
  5. Can non-medical / non-life sciences graduates do clinical research training?
  6. What is included in GCP training in clinical research?
  7. How to prepare for regulatory submissions for clinical trials?
  8. What audits / inspections are clinical trial sites subject to?
  9. How to ensure data integrity and patient safety in clinical research?
  10. What are the best institutes / online platforms for clinical research training in India?

✅ Top Questions for GMP / GCP Audit

  1. What is a GMP audit vs GCP audit?
  2. What are the major requirements evaluated in a GMP audit?
  3. How often should a pharma facility undergo GMP / GCP audits?
  4. What documents are reviewed during GMP / GCP audits?
  5. How to prepare for a GMP audit in India?
  6. What are common findings / non-compliances in GMP / GCP audits in India?
  7. What is the cost of GMP / GCP audit services?
  8. Who is qualified to conduct GMP / GCP audits?
  9. What corrective and preventive actions (CAPA) are usually required after audit findings?
  10. What is the role of internal audits vs third-party audits in maintaining GMP / GCP compliance?

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