We bring the Business Requirement and the Engineering Designing concepts together right at the beginning, to create a manufacturing facility which ticks all the Key Success Factors and create value for the business.
The Key Success Factors that our Turnkey solutions takes care of are:
- Business requirement alignment: aligns the business requirements in terms of volumes and capabilities with the facility
- Right phasing up of the facility: phases the execution of the facility / investment as per the business plan, initial portfolio and geography selected
- Speed & Cost of the project: speeds up the project execution based on an impeccable master plan and benchmarks the cost of the project and the COGs to the best in the industry
- Flexibility to expand as per business needs: allows flexibility for future expansion of the site based on the strategic planning exercise conducted earlier
We study and analyse the market segment thoroughly to arrive at key financial and strategic factors for informed decision making on capital investment into the manufacturing facility.
Master Planning along with concept designing are first steps followed by detailed engineering. We carry out both the activities with precision before the actual execution begins.
We continue supporting our clients in commissioning and installation of the facility. We undertake development of protocols and execution till the final reports.
Through our network we support the facility by sourcing technologies in terms of tech packs of APIs or formulations. The motivation is to initiate business operations as soon as possible.
- Oral Solid Dosages
- Sterile Fill / Finish
- API’s
- High Potency Formulations
- Aerosols
- Semi Solids / Patches
- Medical Devices
- Pilot Plant
- Commercial Plant
- R&D Centers
- Kilo Labs
- Warehouse
- Packaging
Feasibility Analysis
We study and analyze the market segment thoroughly to arrive at key financial and strategic factors for informed decision making on capital investment into the manufacturing facility.
- Market Research
- Strategic Planning
- Business Planning
- Business case formation
- Basic facility designing and project budgeting
Master Planning & Engineering
Master Planning along with concept designing are the most critical steps in a facility set up and serves as a guideline towards basic and detailed engineering development.
- Basic, Conceptual and Detailed designing
- Facility layout with utilities
- Site Master Plan
- User Requirement Specifications
Installation & Commissioning
We continue supporting our clients in commissioning and installation of all the equipment including developing protocols, executing as per the protocols till the final reports. The qualification and validation services include various qualifications of processes, operations and other equipment outputs.
- Cleaning Validation
- Commissioning Documentation and Support
- Circuit OQ and PQ Development, Execution, and Final Reports
- DQ, IQ, OQ and PQ Protocol Development and Execution and Reports
- Development of Traceability Matrices, GAP Analysis
- Risk-based approaches (ASTM E2500, ICH-Q9 principles)
- Equipment Qualification
- Process Validation
- Factory Acceptance Testing / Site Acceptance
Technology Sourcing & Expansion
Maypharm’s network helps our clients to also source technologies in terms of tech packs of APIs or Formulations as the case may be, to speed up the kick of the commercials. The development timelines could be too long hence, in-licensing of tech packs becomes a faster and sure way of getting products in the pipeline of the site.
While Maypharm in-licenses technologies for clients, we also manage the whole program by coordinating with the CDOs and CROs for tech transfer and clinical study management. We offer full-fledged Project Management services as stand-alone service as well from development to filing of dossiers with the regulatory bodies.
- API DMF tech packs
- Formulation dossier tech packs with BA / BE
- Site Transfer Projects to trigger inspections from different regulatory bodies
- Formulation dossier in-licensing for commercialization and tech transfer
- Formulation Technology transfer from a technology based company for supplies in the local markets
