Email

info@qualicaretech.com

Registration No.

GJ16D0007534

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ABOUT

ABOUT US

Qualicare Technology was established with an objective to provide prompt and reliable consulting services to the Pharma sector in the Quality Management System (QMS) and regulatory services, in India and worldwide, with the aim of improving product quality through technological Innovations and upgrades.

Hands-on experience with practical understanding and interpretation in the implementation of Quality Management Systems for pharmaceuticals is the current requirement of the industry. Our consultancy services are used by wide range of suppliers including API, Dosage formulator and Excipient manufacturers. We cater to the current aspirations of the industry to excel in terms of Regulatory Compliance.

OUR APPROACH

Qualicare Technology is committed to delivering efficient, value-added support in obtaining prompt regulatory approvals. Our services span the pharmaceutical, medical device, and biotechnology domains worldwide. We strive to foster enduring, mutually beneficial partnerships with our clients.
We always aspire to provide efficient and value-added support in obtaining quick regulatory approvals for our clients. We also provide a wide range of clinical and regulatory services to the pharmaceutical, Medical device and biotechnology industries worldwide. Our aims is to build mutually rewarding long term partnerships with our clients.

Our Expertise

With 20+ years of experience and he is an expert in API quality management (GMP advisor) and regulatory services (filing 100+ USDMF/COS/EDMFs both for nonsterile and sterile drug substances including peptides and macrolides), Global Quality Auditor and Trainer. Member of European GMP Auditor association (part of the ECA foundation).

Dr. Jayesh Panchal

Ph.D. in Organic synthesis
leader

With 15+ years of experience and he is expert in API quality management (GMP advisor), Quality Auditor and Gap Assessment of the system as per various guideline requirements of US FDA, EDQM, MHRA, ANVISA, COFEPRIS, WHO – Geneva, MCC and PMDA. He is expert in reviewing and guiding on Qualification and Validation activity

Mr. Bhavik Yadav

M.Sc, in Chemistry
leader

Others Expertise

  • Inspection Readiness – Mock Audits and SME Readiness: Equip your organization for inspections through our meticulous mock audits and Subject Matter Expert (SME) readiness initiatives. Identify enhancements and deploy success-oriented strategies.
  • Shop – Floor Compliance Verification: Foster GMP adherence throughout your manufacturing processes with our comprehensive shop-floor compliance verification services. Optimize operations while upholding regulatory benchmarks.
  • Response to Regulatory Inspectional Observations: Swiftly and effectively address regulatory inspection observations with our expert guidance. Develop comprehensive responses showcasing your unwavering commitment to compliance.
  • Remediation for Organizations under Regulatory Enforcement: Tackle regulatory enforcement complexities with strategic remediation plans. We aid in resolving lingering compliance challenges, encompassing Warning Letters and Import Alerts.
  • Independent Data Integrity (DI) and Product Quality Assessments (PQA): Safeguard data integrity and product quality with our specialized assessments. Uphold GMP standards and regulatory expectations with confidence.
  • Training and Capability Building: Empower your team through tailored training programs, equipping them with skills pivotal for success in their roles and fostering your company's achievements.
  • Review and Assessment of Submitted Regulatory Applications: Bolster successful regulatory submissions with our meticulous review and assessment services. Maximize the likelihood of expedited product approvals.
  • Design and Deployment of Quality Management Systems: Forge a robust Quality Management System (QMS) tailored to your requirements. Our experts design, implement, and optimize QMS frameworks, ensuring compliance and operational excellence.
  • GMP Audits and Assessments: Our adept team conducts thorough GMP audits and assessments to ensure your manufacturing processes and facilities align with global standards. Actionable recommendations are provided for optimization and sustained compliance.
  • Quality System Development: Elevate your quality management systems with our guidance, from design and implementation to enhancement. Foster a culture of quality permeating every facet of your organization.
  • Regulatory Compliance: Navigating evolving regulations can be challenging. Our consultants stay updated, helping you interpret and enact them effectively, securing your products' safety and efficacy.
  • Validation Services: Ranging from process validation to equipment qualification, our comprehensive validation services assure reliability, consistency, and GMP compliance in your manufacturing processes and equipment.
  • Training and Workshops: Empower excellence through knowledge. Our customized training programs cover diverse GMP subjects, equipping your team with skills to excel and contribute to your company's triumphs.
  • Gap Analysis and Remediation: Identify practice gaps and guide you through efficient remediation strategies. Our consultants facilitate deficiency resolution and corrective action implementation.
Continuing our journey toward to become reason for success of Pharma industries

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