We provide a wide range of services
Inhalation Services
RNPC handholds you through the complete life cycle of formulation identification, development, and manufacturing. From sourcing and selection of APIs, excipients, components, and packaging materials to facility development for OINDP products, RNPC has the experience that clients need to develop the next generation of medicines-
- Product Development Strategies & Review
- Formulation & Process Development –Advanced Markets (US, EU, ANZ, SA), Latin America, ASEAN, ROW.
- Medical Device Development & Evaluation for Advanced Markets
Inhalation Services
RNPC handholds you through the complete life cycle of formulation identification, development, and manufacturing. From sourcing and selection of APIs, excipients, components, and packaging materials to facility development for OINDP products, RNPC has the experience that clients need to develop the next generation of medicines-
- Product Development Strategies & Review
- Formulation & Process Development –Advanced Markets (US, EU, ANZ, SA), Latin America, ASEAN, ROW.
- Medical Device Development & Evaluation for Advanced Markets
Injectables, Solid Orals and Liquids
RNPC offer a complete portfolio of services related to sterile products, including SVP, LVP, Dry Powder Injectables, Ophthalmic, Cephalosporin products, Tablets, and Capsules. Our team of highly skilled professionals provides regulatory and intellectual property related services as part of this whole
package.Our Services include:
- Product development strategies and reviews
- Formulation & Process development –
- Advanced Markets (US, EU, ANZ, SA)
- Latin America, ASEAN, ROW markets.
- Facility Development –
-
-
- Formulation Development
- Analytical Development
- Pilot Plant
- Commercial Production
-
Injectables, Solid Orals and Liquids
RNPC offer a complete portfolio of services related to sterile products, including SVP, LVP, Dry Powder Injectables, Ophthalmic, Cephalosporin products, Tablets, and Capsules. Our team of highly skilled professionals provides regulatory and intellectual property related services as part of this whole
package.Our Services include:
- Product development strategies and reviews
- Formulation & Process development –
- Advanced Markets (US, EU, ANZ, SA)
- Latin America, ASEAN, ROW markets.
- Facility Development –
-
-
- Formulation Development
- Analytical Development
- Pilot Plant
- Commercial Production
-
Manufacturing Plant Design & Complete Setup- Formulation, API, Excipients & Medical Devices
We work with clients in Greenfield and Brownfield Pharma Projects & support them in all the activities enlisted below to establish fully functional units with full-proof solutions.
- Conceptual designs and plant layouts as per regulatory requirements
- Designing, execution and renovation projects related to Pharma Formulations.
- Handholding through systems and process setup, inspections, and approvals till commercial manufacturing.
- Facility qualification support.
- Regulatory support in expansion projects on running sites with well-conversed risk assessment programs and documentation.
- Turn-Key Projects
Manufacturing Plant Design & Complete Setup- Formulation, API, Excipients & Medical Devices
We work with clients in Greenfield and Brownfield Pharma Projects & support them in all the activities enlisted below to establish fully functional units with full-proof solutions.
- Conceptual designs and plant layouts as per regulatory requirements
- Designing, execution and renovation projects related to Pharma Formulations.
- Handholding through systems and process setup, inspections, and approvals till commercial manufacturing.
- Facility qualification support.
- Regulatory support in expansion projects on running sites with well-conversed risk assessment programs and documentation.
- Turn-Key Projects
Quality Assurance, QMS Services
We make sure that our clients establish and uphold exceptional quality standards. Our extensive experience in a range of areas relating to quality factors support our clients for ensuring quality
which includes:
- Establishment & assessment of Quality Management System (QMS)
- Assessment of all Quality Systems (Manufacturing,
Packaging & Labelling Controls) QMS System, Laboratories Control System, Material, and Inventory Control System, and Facility & Equipment Control System.
- Perform specific audit only for Data Integrity.
- Perform stage 1 Audits and provide pro-active inputs on system implementation and improvement.
- Reviews and Gap Analysis for:
- Regulatory Compliance, Suitability & Adequacy
- Sterility Assurance
- Trend Analysis
- Statistical Process Performance/Capability Analysis
- Annual Product Reviews.
- Support in investigations:
- Failures Investigation
- Guidance, Reporting
- Review and CAPA
- Position Papers
Quality Assurance, QMS Services
We make sure that our clients establish and uphold exceptional quality standards. Our extensive experience in a range of areas relating to quality factors support our clients for ensuring quality
which includes:
- Establishment & assessment of Quality Management System (QMS)
- Assessment of all Quality Systems (Manufacturing…
Packaging & Labelling Controls) QMS System, Laboratories Control System, Material, and Inventory Control System, and Facility & Equipment Control System.
- Perform specific audit only for Data Integrity.
- Perform stage 1 Audits and provide pro-active inputs on system implementation and improvement.
- Reviews and Gap Analysis for:
- Regulatory Compliance, Suitability & Adequacy
- Sterility Assurance
- Trend Analysis
- Statistical Process Performance/Capability Analysis
- Annual Product Reviews.
- Support in investigations:
- Failures Investigation
- Guidance, Reporting
- Review and CAPA
- Position Papers
Qualifications and Validations
Qualification and validation have a big role to play in regulatory compliance and GMP, hence our experts have extensively worked towards making sure that the clients are covered from all the directions.
- Qualification Policies & Strategy
- Validation Master Plan
- Qualification & Validation Protocols & Reports
- Sterility Assurance Plans
- Cleaning Validation
- Computer System Validation
- Process Validation Sterilization/ Bio-decontamination (VHP) Process
- Facility Qualification
- Media Fill/Process Simulation Test
- Analytical Methods (Chemistry & Microbiology)
- Qualification of Manufacturing Equipment
- On-Site Validation Service for Manufacturing Equipment
- Engineering Systems Validation
- Purified Water System Validation
Qualifications and Validations
Qualification and validation have a big role to play in regulatory compliance and GMP, hence our experts have extensively worked towards making sure that the clients are covered from all the directions.
- Qualification Policies & Strategy
- Validation Master Plan
- Qualification & Validation Protocols & Reports
- Sterility Assurance Plans
- Cleaning Validation
- Computer System Validation
- Process Validation Sterilization/ Bio-decontamination (VHP) Process
- Facility Qualification
- Media Fill/Process Simulation Test
- Analytical Methods (Chemistry & Microbiology)
- Qualification of Manufacturing Equipment
- On-Site Validation Service for Manufacturing Equipment
- Engineering Systems Validation
- Purified Water System Validation
Regulatory Support and Compliance
Our regulatory compliance support services help clients to focus on their core business activities, confident that they are fully compliant with all regulatory requirements. Our team of experts’ support in-
- Product Dossier Building
- Product Technology Sourcing and Tech Transfer
- Designing in-vitro BA BE Studies and Management of the Studies.
- Data Interpretation
- Regulatory Filing (Including Advanced Markets)
- Regulatory Compliance – Response Strategy and Response Drafting, Preparation, Review
Regulatory Support and Compliance
Our regulatory compliance support services help clients to focus on their core business activities, confident that they are fully compliant with all regulatory requirements. Our team of experts’ support in-
- Product Dossier Building
- Product Technology Sourcing and Tech Transfer
- Designing in-vitro BA BE Studies and Management of the Studies.
- Data Interpretation
- Regulatory Filing (Including Advanced Markets)
- Regulatory Compliance – Response Strategy and Response Drafting, Preparation, Review
Operational Excellence, Lean Management and Cost Optimization
We understand that operational excellence, lean management, and cost optimization are critical factors for success in the pharmaceutical industry. The following activities have helped clients to optimize operations, reduce waste, increase efficiency, and ultimately, improve their bottom line
- Operational Excellence for Manufacturing Plants:
- Capacity Enhancement
- Productivity Improvement
- Wastages Reduction and Yield Improvement
- Quality Improvement
- Resource Optimization
- General Management: Executing Critical Business Projects, Strategy Planning for Different Plants.
- Team Management: Sharing a Common Vision, Goal Setting and Monitoring, Coaching & Mentoring on Operational Excellence.
- Learning & Development/Global Trainer: Certified Lean & Six Sigma Global Trainer, Coaching for Success, Industrial Engineering Tools Coach, Developing People and Motivating for taking Initiatives, Training on IE/Lean tools for different locations in operation & certification of different skills.
Operational Excellence, Lean Management and Cost Optimization
We understand that operational excellence, lean management, and cost optimization are critical factors for success in the pharmaceutical industry. The following activities have helped clients to optimize operations, reduce waste, increase efficiency, and ultimately, improve their bottom line
- Operational Excellence for Manufacturing Plants:
- Capacity Enhancement
- Productivity Improvement
- Wastages Reduction and Yield Improvement
- Quality Improvement
- Resource Optimization
- General Management: Executing Critical Business Projects, Strategy Planning for Different Plants.
- Team Management: Sharing a Common Vision, Goal Setting and Monitoring, Coaching & Mentoring on Operational Excellence.
- Learning & Development/Global Trainer: Certified Lean & Six Sigma Global Trainer, Coaching for Success, Industrial Engineering Tools Coach, Developing People and Motivating for taking Initiatives, Training on IE/Lean tools for different locations in operation & certification of different skills.
Mergers & Acquisition (M&A), Investments & Joint Venture (JV)
Our M & A Division provides supports to the companies which are active in the pharmaceutical and healthcare sectors in searches for M&A opportunities worldwide. We provide our clients with search and consulting services in relation to:
- Debt Finance – General Debt and Corporate Debt, Special Situation Finance.
- Investments – Private Equity / Venture Capital Investments against Minority / Majority Stakes in Company.
- Acquisition – Strategic Acquisitions OR Acquisitions through Domestic or International Institutions.
- Valuations and Due Diligence – Company Valuation and Due Diligence in case of Stake Selling / Acquisitions
- Transaction Advisory – Create a path for successful deal execution and a win – win situation at both the ends.
- Post Deal Due Diligence – To check over the things at the end of investee on behalf of investor.
- perform business operations with ease and clarity with total control
Mergers & Acquisition (M&A), Investments & Joint Venture (JV)
Our M & A Division provides supports to the companies which are active in the pharmaceutical and healthcare sectors in searches for M&A opportunities worldwide. We provide our clients with search and consulting services in relation to:
- Debt Finance – General Debt and Corporate Debt, Special Situation Finance.
- Investments – Private Equity / Venture Capital Investments against Minority / Majority Stakes in Company.
- Acquisition – Strategic Acquisitions OR Acquisitions through Domestic or International Institutions.
- Valuations and Due Diligence – Company Valuation and Due Diligence in case of Stake Selling / Acquisitions
- Transaction Advisory – Create a path for successful deal execution and a win – win situation at both the ends.
- Post Deal Due Diligence – To check over the things at the end of investee on behalf of investor.
- perform business operations with ease and clarity with total control
Intellectual Property Rights Management
A good understanding of IP provides a strong backbone to a company and we have helped our clients to leverage upon their creations to excel in the industry. We provide our clients with the following support in IP Management:
- File patents.
- Search for the most suitable trademarks and designs
- Obtain expert opinions on patent search and support in related formulation & medical device development strategies.
Intellectual Property Rights Management
A good understanding of IP provides a strong backbone to a company and we have helped our clients to leverage upon their creations to excel in the industry. We provide our clients with the following support in IP Management:
- File patents.
- Search for the most suitable trademarks and designs
- Obtain expert opinions on patent search and support in related formulation & medical device development strategies.