Our wide-range of consulting services to establish Quality Systems for Drug development, scale-up, technology transfer, commercialization and post-inspection response and Remediation supports. This includes the following areas of the industry.
- Setting-up effective Quality Systems suitable to the size and complexity of the processes and operations.
- Harmonization of SOPs /policies / procedures including Quality Plan, Validation Master Plan and Site Master Plan for the operations.
- Facility Assessment to identify gaps and opportunity for improvement in processes / systems.
- Prepare Equipment Qualification Master Protocol, Execution checklist and compilation of Qualification summary reports.
- Provide Process Validation and Cleaning Validation guidance and related documentation.
- Preparing for an inspection to face regulatory audits including Mock-inspection, SMEs and documents readiness, and follow- up for the compliance.
- Quality Risk Management(QRM) and Quality investigation for Market complaints and Manufacturing deviations.
- Supplier qualifications including Due diligence, site audits and periodic evaluations for APIs, Excipients, Primary. packaging materials and contract service providers.
- Third-party release of batches through monitoring of batch processing including review of batch records and laboratory records.
- Quality Supports to define strategy for decommissioning and relocation of the Equipment/ Facility.
- Quality systems integration during merger / acquisition of new firm.
- Prepare response for Regulatory Inspection and Remediation Planning.
- Pharmaceutical Facility Qualification Services for starting up new facilities and expanding existing production capacity as required.
- Provide On-site and Virtual GMP training on various topics as required by the companies.
