At ProGrow Pharma Partners, we provide exceptional consulting services in Regulatory consulting, Quality & Compliance, and Computer System Validation (CSV). We support pharmaceutical, biotech, nutraceuticals, lifesciences, and medical device companies navigate complex regulatory landscapes efficiently and cost-effectively. 

Explore our comprehensive services and discover how we can support your business in achieving compliance, quality excellence, and regulatory success.

 

Regulatory Consulting Services

Regulatory consulting services help pharmaceutical companies navigate the complex landscape of regulatory requirements. We offer a full range of life science Regulatory consulting services. We provide the best practices and proven insights on program and process management that are aligned with our mission to improve the health and safety of patients in a cost-effective manner.

We assist with:

• Regulatory submissions: Preparing and submitting documents.
• Regulatory strategy: Developing a comprehensive plan for regulatory submissions and approvals.
• Compliance audits: Conducting internal audits to ensure adherence to regulatory standards.
• Regulatory intelligence: Keeping advanced with regulatory changes and updates.

 

Quality Assurance Consulting Services

Quality Assurance consulting focuses on ensuring that pharmaceutical companies meet the highest industry standards. We assess processes, procedures, and products to ensure compliance and improve quality. Our Quality Assurance consulting services span the pharmaceutical, biopharma, active pharmaceutical ingredient (API), and medical device industries. With hands-on experience in project management, risk assessment, and validation, we ensure the highest quality of services.

Our services include:

• Quality system audits: Conducting audits to assess compliance with standards like US CFR Part 210 and 211, ICH, and EU GMP.
• Quality management systems: Designing, implementing, and maintaining systems for managing quality records, deviations, investigations, change controls, and CAPAs.
• Training: Providing training to employees on quality control measures and regulatory guidelines.
• Risk management: Identifying potential risks and developing strategies to mitigate them.

 

Computer System Validation Consulting Services

Computer System Validation (CSV) consulting ensures that computer systems used in pharmaceutical manufacturing and quality control are validated and compliant with regulatory standards. We have special domain expertise in computer systems validation of manufacturing (MES) and quality control, including LIMS, QMS, GMP, GLP audits of sites and risk assessment of new and existing computer systems, and review/ evolution of CSV policy in line with the latest guidelines from EMA and US FDA.

Services include:

• Validation planning: Developing validation plans tailored to the system’s risk level.
• User requirements: Documenting user requirements and functional specifications.
• Validation protocols: Creating IQ, OQ, and PQ protocols to test system functionality.
• Inspection-ready documentation: Ensuring that validation deliverables meet industry standards and can withstand regulatory inspections.
• Ongoing support: Providing continuous support and education to staff on software quality assurance SOPs and validation templates.