Hire NovaChrom Consultancy Service LLP, a pharma consultant specializing in Analytical Testing, FDA Inspections, Pharmaceutical Manufacturing and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Consulting Firm
Expertise summary: NovaChrom Consultancy Service LLP is a pharmaceutical consulting firm providing technical, quality, analytical, and compliance support to pharmaceutical manufacturers and laboratories. Its expertise includes GMP audits, supplier qualification, FDA inspection readiness, quality management systems, and GMP compliance. The firm also offers analytical development, method validation, process validation, and qualification of analytical and quality control instruments. Its services combine supplier assessments, laboratory reviews, data integrity assessments, documentation support, and remediation planning to help clients identify compliance gaps and strengthen manufacturing and laboratory operations. - Show More
NovaChrom offers analytical method development and laboratory support for pharmaceutical projects. Its services combine analytical expertise with technical documentation review to support product development and testing needs. Through its integrated laboratory service offering, the firm helps clients develop methods and generate analytical information for subsequent validation and quality assessment.
NovaChrom supports the installation, qualification, and validation of analytical and quality control instruments, including refurbished equipment. Its laboratory instrument services also include calibration and maintenance support. The firm helps clients establish suitable instrument controls and supporting documentation for reliable laboratory operations.
NovaChrom supports FDA inspection preparation through facility audits and assessments of gaps against regulatory expectations. The firm helps organizations identify weaknesses in quality systems, laboratory practices, and documentation, then develop action plans to improve preparedness. Its approach includes technical review and remediation support for pharmaceutical operations.
NovaChrom provides GMP audits and gap assessments for pharmaceutical facilities and API suppliers. Its work includes reviewing quality practices, laboratory compliance, data integrity, and technical documentation. The firm helps clients identify deficiencies and establish remediation priorities, with assessments covering ICH Q7 and relevant manufacturing requirements.
NovaChrom helps pharmaceutical organizations assess and improve GMP compliance through quality reviews, laboratory assessments, and technical documentation checks. Its work includes identifying compliance gaps, reviewing data integrity controls, and supporting corrective actions. The firm provides practical technical assistance to help clients strengthen routine operations and maintain inspection preparedness.
NovaChrom provides analytical method validation and verification services to assess whether methods are suitable for their intended use. Its offering covers performance characteristics such as accuracy, precision, and robustness. The firm supports pharmaceutical laboratories with validation activities and documentation aligned with applicable analytical requirements.
NovaChrom provides process validation support within its pharmaceutical technical services portfolio. The firm helps clients assess validation needs and supporting evidence in the context of product development and manufacturing compliance. Its validation offering complements its quality system, gap assessment, and technical documentation services.
NovaChrom supports the design, implementation, and maintenance of pharmaceutical quality management systems. Its services include SOP management, deviation handling, CAPA, change control, and data integrity support. The firm also provides computerized system validation services to support reliable electronic quality processes.
NovaChrom supports pharmaceutical supplier and vendor qualification through audits, technical due diligence, and quality assessments. Its services help clients evaluate API suppliers and other pharmaceutical partners, review supporting documentation, and identify technical and compliance risks. The firm also offers India-based execution support for international clients requiring local supplier assessments.
