GCP Consultancy and Audits
offers GCP auditing and consultancy services including:
Global reach : Experienced in conducting GCP audits in India, Australia, Japan, Malaysia, Philippines, Singapore, South Africa, South Korea, Thailand and Vietnam.
- Study/Trial Master Files audits
- Study documents (Protocol, Informed Consent, Clinical Study Reports) audits
- Clinical Investigative Sites audits
- Clinical Databases audits
- Statistical Programming (Tables, Figures/Graphs and Listings) audits
- Pharmacovigilance audits
- Third party vendors audits (including Clinical laboratories, CROs, Drug depots, Phase I Units, Bioequivalence/Bioavailability Units (including Bio-analytical labs), Translators and Ethics Committees)
- For cause situations (including root cause analysis and Corrective and Preventive actions (CAPA) program) Process audits
- Management of audit programs
Management of Bioavailability/Bioequivalence Studies
offers high level Project Management and Monitoring of BA/BE Studies including:
- Project contract, budgeting and negotiation
- Time management from protocol design to report submission
- Project initiation and in-study monitoring
- Site Selection/Qualification Visits
- Site Initiation Visits
- On-Site Monitoring Visits
- Site Closure Visits
- Remote Monitoring
- Technical discussion
- Timely and extensive update to clients about the study progress
- Bio-analytical Monitoring
- Scientific document writing (protocol, Consent forms, Case report forms, clinical study report (clinical phase, bio-analytical phase, PK and Statistical phase of the report)
- Regulatory Affairs (DCGI submission, BE NOC and T- License)
monitored more than 70 bioequivalence projects for US FDA and EU submissions. Extensive experience in qualification of BA/BE centers.
System/Facility Audit of BA/BE Centers:
experience of auditing more than 10 BA/BE CRO’s in India for number of times.
Validation and Compliance Services for Computer Systems
provides total validation services to ensure that your Computer Systems are compliant with FDA, GxP, 21 CFR Part 11, Other Governmental regulations and industry standards.
- Validation Strategy and Implementation
- Computer Systems Validation
- Network and Infrastructure Qualification
- Document Management Systems
- Clinical Trials Systems
- Drug Safety Systems
- Quality Management Software (QMS)
- EDC Systems
- CAPA Systems
- Prospective and Retrospective Validation
- Validation Staffing
- Validation Documentation including Validation Master Plan, IQ/OQ/PQ, Traceability Matrix, Summary Reports
- GAP Analysis and Risk Assessments
- Vendor Audits
- Quality Review Services
- Technical Writing
- CSV Training
- Validation Services - Laboratory and Equipments
- provides complete Laboratory and Equipments Validation Services to ensure that your lab systems and equipments meet GLP, GMP and GCP standards along with 21 CFR Part 11 and other industry standards and regulations.
- Our Services include:
- Development and Implementation of Validation Master Plans.
- Develop and Execute IQ/OQ/PQ for Laboratory Systems and Equipments.
- Develop Standard Operating Procedures (SOPs) for Administration and Maintenance of equipments related to Computer Systems.
- Conduct GAP Analysis, Risk Assessments and Develop Remediation Plans.
- Evaluation of Current Compliance States.
- Quality Review of Documentation, Protocols and SOPs
- Lab Systems: HPLC's, LCMSMS, Scientific Data base Management System (SDBMS), Bio-analytical LIMS.
Holistic Project Approach:
Proven Project Life Cycle Expertise:
- Compliance Services
- Global businesses in regulated industries turn to RS Serve to achieve compliance within an increasingly complex regulatory environment. With a proven track record on global compliance projects, our people help companies keep their systems in a state of validated compliance without losing operational flexibility and productivity. In fact, RS Serve teams are regularly recognized by our customers as having delivered on time, within budget and with energy and commitment.
- Our successes from continuing inspections by worldwide regulatory bodies are a testament to the quality and relevance of our approach for compliance for every client. Our compliance services meet your specific needs due to our unique approach.
- Comprehensive Risk Assessment/Analysis:
- Root cause analysis
- Functional risk assessment
- Site-applicable risk assessment
- Based on global industry regulations such as FDA, EMA etc.
- Full gap analysis
- Protocols, work instructions, and standard operating procedures development
- Effective knowledge transfer
- On-going managed services
- Extensive library and repository of industry-related documents, processes and guidelines
- Long history of experience in the life sciences sector
- Basis for continuous compliance throughout project phase(s) and beyond
- Audits and compliance inspections
offers GMP compliance services including:
- Quality Management System implementation and gap analysis
- Good Manufacturing Practice reviews
- Quality audits of manufactures, suppliers, distributors and contractors of both sterile and non-sterile APIs and Finished Drug Products
- Process validation, analytical validation and equipment qualification support
- Quality Assurance and Quality Control operational support
- Regulatory inspection readiness preparations
- Documentation design, generation and maintenance support
- Quality Risk Assessment and mitigation support
- Training of staff in areas of Pharmaceutical manufacturing both aseptic and non-aseptic
- Clinical manufacturing and packaging.
Training/Mock Inspection/SOP Development and Management
We provide complete as well as customized trainings on:
We have prepared and hosted inspection by various regulatory agencies including DCGI – India, UK MHRA, US FDA, EMEA, Taiwanese FDA, Vietnamese MoH, South Korean FDA, ANVISA – Brazil, WHO, MCC – South Africa and Israel – MoH. These include inspection conducted at BA/BE centers, investigators sites, CROs and sponsor location.
- Standard Operating Procedures (SOPs)
- Good Clinical Practice (for CROs, Investigators and Coordinators, CRAs and clinical trial managers)
- Computer System Validation
- GCP auditing skills
- Regulatory Inspection Preparedness
- Mock Inspection:
- Mock GCP Regulatory Inspections
- Investigative Site Training and Preparedness
- In process Inspection Support and Facilitation
- Response creation
- SOP Development and Management:
- Process Assessment and Mapping (Flow Chart)
- Gap Analysis
- SOPs Development and Administration