Regulatory Services
We, at skylimit, believe that inspection readiness is more than a “one time” event. As inspections can occur at any time and we need to be ready to act during any such event. We ensure that we leave no stone unturned.
- Adequately trained staff is available to perform study related activities. Training is ensured by seniors before delegating any study related activities.
- All study related documents are promptly filed in the trial master files and ensured that all these documents are complete with all relevant details.
- Facility readiness is ensured by continuous verification of the systems and documents.
- In-house quality monitors team conduct review of processes and documents during study conduct thereby ensure the compliance to study protocol requirements.
- In-house quality assurance team conduct system/facility and equipment based audits periodically to check the compliance with in house procedures and study audits to verify the compliance with study protocol.
- Senior management continuously monitors the quality systems of various departments to ensure that all standard processes and practices are implemented, thereby ensuring all time audit readiness of various facilities.
- To achieve the regulatory goal, we can suggest a concrete regulatory strategy to give you a competitive advantage.
- Provide detailed feasibility before study execution to get real-time information and expected timelines.
- Preparation & submission of regulatory documents for obtaining.
- Approval to conduct a clinical trial in India.
- Approval to import Investigational Products.
- Central Bureau of Narcotics (CBN) and State FDA permit to import Narcotic and Psychotropic substances.
- Liaising and Obtaining registration documents in the interest of clients
- Continuous follow-up post submission with regulatory authorities
- Safety reporting
- Preparation of regulatory submissions in CTD and eCTD format
- Preparation of summaries required for generic submission
- Executing regulatory submission
- Responding to the health authorities’ queries during the approval phases of the product
Quality Assurance Services :
Skylimit provide elevated experiences guided by our aim to deliver best-in-class Quality Assurance, ensuring compliance and supporting clinical study leading to market approvals so that together, we can improve lives through transformative clinical research.
Our Quality Assurance team has the right knowledge and in-depth expertise to ensure effective quality oversight and help you navigate global regulations and compliance requirements.
We adhere to ICH-GCP, GCLP, ALCOA+, 21 CFR Part 11, ISO 15189, ISO 17025 and GAMP-V standards and applicable regulatory requirements and guidance in the regions where we deliver services, ensuring compliance with local regulations, by leveraging local expertise and taking a risk-based approach. All our team members are trained on quality and regulatory compliance and standard operating procedures that also anticipate and comply with regional or local regulatory requirements and our robust, harmonized Quality Management System (QMS) means we can assure you that everyone on your project team has been trained to meet the same high standards. Our deeply experienced, QA team, have extensive past experience in strategically preparing for, hosting, managing and closing out regulatory inspections for our clients, supporting dozens of client audits annually with minimal to no findings including inspections from various regulatory bodies where we work, such as MHRA, HC, USFDA, NDCT 2019, NPRA, WHO,EMEA ROW among others.
Robust Quality Assurance :
- Full audit program of internal and external audits.
- Hosting and close out of inspections.
- Regular Executive leadership review and feedback on the QMS effectiveness.
- Vendor Qualification.
- Ensuring Inspection and Audit-readiness, through staff training.
- Development, maintenance of robust Quality Management system, standards, SOPs, staff training and metrics.
- Regulatory authority inspection support.
- Gxp system risk assessment, validation, change control/management and periodic review.
- Documentation review.
- GxP investigations/deviation reports/Quality Event/CAPA system.
- Training