Design and Development
- Converting an idea or concept into Engineering drawings
- Transforming drawings and simulations
Prototyping
- Conversion of drawings and simulations into a functioning prototype
- Crystallizing the different technical specifications for the prototype from the concept stage
- Identification of the ideal components to meet the specifications
- Fabrication of the components through their different iterative stages
- Technical Negotiation with vendors to identify the best fit for the components required
- Final assembly of the Prototype
Testing and Validation
- Rigorous testing to validate the functioning of the prototype
- Preparation of custom equipment to aid us in product testing
Manufacturing
- Design transfer to transform a prototype into a packaged product for the market
- Quality Management System development to maintain Quality of the manufactured product
- Preparation of SOPs, Work Instruction, Batch Manufacturing Records to maintain manufacturing quality, reproducibility and traceability
- Packing Design and Fabrication
- Customized Process Equipment
- Contract Manufacturing of sterile and unsterile products
Regulatory Support
- We are also experienced in Document Management to prepare regulatory documents to meet the different licensing requirements
- We have expertise in the end to end regulatory filings across the life cycle of a new product – from concept, risk management to post market surveillance