In the live regulatory scenario, consistent GMP & Regulatory compliance on a day to day basis makes a good business sense. Industry finds it tough to consistently sustain compliance standards along with rigorous regulatory/customer inspections of the facilities and GMP systems.
We customize our project plan for you based on our understanding of the global regulatory landscape and proven expertise within the Pharmaceutical Industry. With top-caliber professionals in the industry, we can set our foot on the War Ground and provide end-to-end customized solutions for a project.
RQuaL has the capability and potential to handle any level of project. We can integrate seamlessly with your team and work as per their requirements to provide a workable solution that the team can accomplish in a time bound manner. We believe in working with your team to get the maximum output in the shortest possible timeline.
RQuaL promises to stand by you with its "Auditing Services" to meet the stringent current regulations of various authorities. Our experts with decades of ground experience in auditing/inspection can provide you with high standard compliance audit findings and customized ready-to-use solutions. RQuaL helps to prepare the team and enhance their compliance standards to succeed during a Regulatory Inspection.
RQuaL ensures to get the right set of experts on ground to do a GEMBA and provide Customized & Practical Solution.
Audits
- 1. Site Due Diligence
- 2. Initial Facility Designing
- 3. Improvements in Facility Design
- 4. HVAC Systems
- 5. Water Systems
- 6. Equipment Selection/Optimization
- 7. Qualifications and Validations
- 8. Vendor Audits and Qualification
- 9. Vendor Evaluation
RQuaL has the expertise to perform full Site Due Diligence for assessing a facility on gaps and risks associated with historical activities related to GMP.
We assist the organizations to build GMP into systems by assessing the design at the initial stage so that the system can sustain all the Green Regulations. We also do retrospective assessment of the facility design for upgrading and meeting the current audit expectations. Our team has the expertise to support complex matters of HVAC/Water system design.
We help in the selection of the right Equipment / Instruments for the facility and their Qualifications and Validations as per the current guidelines.
Vendor selection is the key to First Time Right product. We assist in Vendor audits for Key Starting materials, Intermediates, Active Pharmaceutical Ingredients, Excipient, Primary Packaging material. We also undertake audits of Finished dosage form manufacturers, Research and Development Labs, Analytical laboratories, Distributors, Transporters etc.
Investigative Activities
- 1. Documentation, DI Review
- 2. Troubleshooting & Risk Analysis
- 3. Investigations and RCA
- 4. CAPA Management
- 5. Quality Risk Management
- 6. Preparing Internal Auditors
- 7. GxP System Improvements
RQuaL helps the organizations to do investigations and Risk analysis for various activities critical to GMP and Product Quality. We help in GEMBA walks along with the local site team and do the Investigations, Troubleshooting, Risk based Root Cause analysis and assist in developing CAPA as per specific requirements.
We also undertake projects to groom internal Auditors with the skills required to audit and do self assessments for Site GxP Improvements.
Process Optimisation
- 1. cGMP Automation Software
- 2. Training Process Setup
- 3. Specialized Subject Training
- 4. Aseptic Processing Compliance
- 5. Sterilizations
- 6. Advanced Manufacturing
- 7. Operation Excellence / PAT
- 8. Analytical technology
- 9. Analytical Services Optimization
- 10. Technology Transfer
RQuaL assists the organizations for Optimizing their current processes and GxP activities.
Training has always been the core to Growth of an organization. We help in developing the optimum training process for the organization as per the company setup.
RQuaL specializes in both Sterile and Non-Sterile process activities. We set up the growth process in the organization using the Advance Manufacturing module, leading to Operational Excellence. We also help in setting up Analytical Labs and Process Analytical Technology for complex processes.
Regulatory Support
- 1. Regulatory Filing
- 2. Maintenance and Responses
- 3. Regulatory Compliance
- 4. Pre-Inspection Audit
- 5. Regulatory Audit Preparedness
- 6. Site Readiness
- 7. Team Building - SMEs
We take up DMF preparation for specific regulatory bodies by getting involved from the very beginning of the planning stage to the final DMF filing. We also help in Maintenance and formulating optimized responses to the Authorities on the queries raised on the filed DMFs.
We help the sites in developing processes to comply with the filed DMFs and do regular audits for compliance verification.
We do undertake projects on preparing the site for Regulatory Audits. We help in developing the Site Subject Matter Experts who will be confident in handling all the audits.
RQuaL has the expertise to perform Pre-audits to assure site readiness for Health Authorities Inspections.
- Rich Industrial Experience in Quality Compliance and Regulatory Affairs
- Thorough understanding of Regulations and Guidelines
- Expertise in Global Regulatory Strategy and Operations
- Project Approach
- Integrate seamlessly with the Ground team
- Provide cost effective Customized, Workable and Sustainable solutions
- Regular Monitoring of CAPA
- Time-bound Project completion
- Data Integrity Compliances
- Process Optimization - Operational Excellence
- Health Authority Enforcement Action Response and Remediation
- Coaching and Mentoring
RQuaL believes in providing wholesome solutions to our valued clients and puts all efforts in building long lasting relationships.
We don’t just advise on how to achieve a successful outcome but promise to work alongside the Ground Team to get the Project accomplished in a Time Bound manner.