We Expertise In
Pharmaceutical and Healthcare
1. Manufacturing Line Setup
We excel in creating advanced manufacturing lines tailored for medical device production. Our expertise encompasses layout design, equipment selection, and validation processes, ensuring operational efficiency, compliance, and scalability. Our commitment to quality includes cleanroom design, equipment installation, and comprehensive staff training.Our pharma validation expertise:
- Equipment validation
- Facilities validation
- HVAC system validation
- Cleaning validation
- Process validation
- Analytical method validation
2. Audit Preparation and Support
Our audit preparation services guarantee readiness for regulatory inspections. We conduct thorough gap analyses and mock audits to identify areas for improvement, providing documentation support to minimize compliance risks.We also assist clients in interpreting audit findings, prioritizing corrective actions, and implementing Corrective and Preventive Action (CAPA) plans for sustainable improvement.
Quality System Services Provided:
- GxP Training and Audits
- Quality Agreement Preparation
- Authoring Quality Manuals and Procedures (SOP)
- Preparing Work Instructions and Process Maps
- CAPA Program Development and Implementation
- Compliance Remediation Support (Warning Letters, Complete Response Letters, and Consent Decrees)
- Risk Assessment
- Validation Approach
3. Process Development and Quality Engineering
Our focus on process development emphasizes optimizing workflows and ensuring regulatory compliance. We leverage advanced quality engineering techniques and data analytics to drive continuous improvement and enhance cost-effective manufacturing. Our services include risk assessment, quality control, and the streamlining of processes to deliver high-quality products consistently.Quality System Services Provided: Risk Assessment: Implementing proactive risk management strategies.
Statistical Analysis: Utilizing statistical methods to validate designs and processes.
Regulatory Compliance: Ensuring adherence to industry standards and regulations.
Medical Device Manufacturing Process Validation:
- Cleaning Validation
- Supplier Quality Validation
- Electrical System Validation
- Utilities/HVAC Validation
- Computer System Validation (CSV)
- CAPA Owners/ Investigators
- Quality Assurance
- Thermal Validation
- Packaging Validation
- Passivation process Validation
- Sterilization process Validation.
4. Computer System Validation
Computer System Validation (CSV) services ensure that computer systems in regulated industries, such as pharmaceuticals, biotechnology, and medical devices, comply with regulatory requirements and operate as intended. These services are crucial for ensuring data integrity, system reliability, and compliance with industry standards like FDA regulations (21 CFR Part 11) and EU Annex 11.- System Design and Development
- Testing and Qualification
- Documentation
- System Release and Maintenance
- Training and Support
Regulatory Affairs Expertise
Regulatory services in the pharmaceutical industry are essential for ensuring that drugs and medical products meet all necessary legal and regulatory requirements before they reach the market. Our services help pharmaceutical companies navigate complex regulatory environments, ensure compliance with global standards, and facilitate the approval of new products.Regulatory Services Provided:
- Regulatory Strategy and Planning
- Product Registration and Dossier Preparation
- Regulatory Submission Management
- Clinical Trial Applications and Support
- Post-Market Surveillance and Compliance
- Regulatory Audits and Inspections
- Global Regulatory Support
Are you ready
to navigate the world with confidence with VSGM??
You are at the right place, We got you- “A Global Validation Support Tailored for You.”