Ingenuity Pharma Services (IPS)

Complete Pharmaceutical Industry Consultancy in accordance to:

  • WHO Guidelines
  • European GMP
  • PICS

Ingenuity Pharma Services (IPS) is a recognized leader in delivering end-to-end pharmaceutical services. With a profound understanding of the unique challenges and intricate needs of pharmaceutical companies, IPS stands as a beacon of excellence in delivering a one-window solution. We have a proven track record of driving operational efficiency, ensuring regulatory compliance, and fostering innovation within the pharmaceutical industry.

We provide comprehensive and tailored solutions to the pharmaceutical industry in following key areas:

  1. Regulatory Affairs
  2. QA and QMS System Deployment
  3. Qualifications & Validations
  4. Microbiology Services
  5. Research & Development (R&D)
  6. Warehousing Solutions
  7. Material Procurement
  8. Training & Development of Technical team

1. Regulatory Affairs

Our Regulatory Affairs team specializes in navigating the complex landscape of pharmaceutical regulations and compliance. We work tirelessly to ensure that MP Pharmaceutical’s products meet the highest standards of safety, quality, and efficacy while adhering to global regulatory requirements.

  1. Regulatory strategy development
  2. Preparation and submission of regulatory documents
  3. Product labeling and packaging compliance
  4. Regulatory intelligence and compliance monitoring
  5. Interaction regulatory authorities
  6. Global market access and strategy
  7. Regulatory training and education

2. QA and QMS Deployment

We understand the critical role that Quality Assurance (QA) and an effective Quality Management System (QMS) play in ensuring product quality, regulatory compliance, and customer satisfaction. Our QA and QMS System Deployment Services are designed as per WHO guidelines to instil a culture of quality within MP Pharmaceutical, ensuring that products meet the highest quality standards while maintaining regulatory compliance throughout the product lifecycle.

  1. Quality Management System (QMS) Development
  2. Gap analysis and compliance assessment
  3. Document control and management
  4. Standard Operating Procedures (SOP) for organization
  5. Training and competency development
  6. Supplier and vendor qualification
  7. Deviations, RCA, risk management, and CAPA programs
  8. Internal and external audits handling
  9. Key Performance Indicators and Metrics

3. Qualifications & Validations

At Ingenuity Pharma Services (IPS), we recognize the critical importance of ensuring that pharmaceutical facilities, equipment, and processes are fully qualified. Our Qualification & Validation Services are designed to systematically verify and document that all critical systems operate within specified parameters and meet predefined quality and compliance requirements, this includes:

  1. Design Qualification (DQ)
  2. Installation Qualification (IQ)
  3. Operational Qualification (OQ)
  4. Performance Qualification (PQ)
  5. Process Validation (PV)
  6. Cleaning Validation (CV)
  7. Computer Software Validation (CSV)
  8. Analytical method validation
  9. Facility qualification
  10. Equipment qualification
  11. Data integrity audits

4. Microbiology Services

Our Microbiology division is dedicated to providing comprehensive and state-of-the-art validation services to ensure the safety and quality of pharmaceutical products. We employ advanced methodologies and adhere to stringent regulatory guidelines to help MP Pharmaceutical meet its microbiological testing requirement.

  1. Environmental monitoring
  2. Microbial identification
  3. Sterility testing
  4. Validation of sterilization processes
  5. Microbial limit testing
  6. Preservation Efficacy Testing (PET)
  7. Bacterial Endotoxin Testing (BET)
  8. Bioburden testing

5. Research & Development

Our R&D division is committed to driving innovation and advancing pharmaceutical product development. With a team of experienced scientists, we offer a range of services to support MP Pharmaceutical in bringing cutting-edge products to market.

  1. Formulation development
  2. Analytical method development & validation
  3. Preclinical studies
  4. Stability studies
  5. Dissolution & release testing
  6. Impurity profiling and characterization
  7. Scale-up & technology transfer
  8. Intellectual Property (IP) & patent support

6. Warehousing Consultancy

Our Pharma Warehousing Consultancy Services are designed to optimize the storage, handling, and distribution of pharmaceutical products, ensuring compliance with regulatory standards and best practices. We offer expert guidance and solutions to enhance the efficiency, security, and compliance of MP Pharmaceutical’s warehousing operations.

  1. Warehouse design and layout
  2. Temperature controlled storage solutions
  3. Cold chain management
  4. Good Distribution Practices (GDP), Good Storage Practices (GSP), and other relevant regulatory standards.
  5. Security and access control
  6. QMS for warehousing
  7. Technology integration
  8. Temperature monitoring system for wareshouse
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