As part of our endeavor to provide end to end solutions to the life sciences sector, Elomatic today is in position to facilitate Technology transfer, Product Dossier, Analytical testing services and Third Party Regulatory support through its globally renowned principals based in Europe, Asia and North America.
Elomatic has access to provide the technologies for production of complex molecules such as monoclonal antibodies, therapeutic protein, generic & novel vaccines, bio-enzymes, classical fermentation based products as well as dossiers for chemical synthesis based formulation & API products. Our analytical services range from providing cell bank characterization to neurovirulence testing and so on.
Effective teamwork, information sharing & clear communications among the development team or ownership team and manufacturing team significantly rationalizes the transfer of technology. Ideally points of communication and working groups are well established for the facilities that understand manufacturing details, limitations, operational strategies, regulatory demand and flexibility for the facilities. Additionally Environment, Health And Safety (EHS) representatives are consulted for any potential issues before formal selection.
Finally, a formal sourcing decision is made considering a wide variety of factors from business, operations, production schedule and capacities. All team members will be aligned to the overall mission including the vital deliverables for the technology transfer. A formal process transfer plan is useful to document and clarify the technology transfer objectives, deliverables, timeline, technology transfer team responsibilities, and provide an overview of the risks with associated mitigations.
The technology transfer team thoroughly monitors the process implementation, in process outcomes, and operational observations during the first process batch manufacturing campaign. The process results deliver early sign of the technology transfer success and identify requirements for changes prior to subsequent batch manufacturing, if applicable.
Elomatic has also made provisions for third party regulatory reviews through its principals that have knowledge in this field and have hands on experience through their prior association to globally renowned regulatory bodies.
Regulatory Compliance : Advisory Services
- cGMP (current Good Manufacturing Practice) compliance
- Advisory services to queries pertaining to Pharma GMP, GLP, QA and regulatory affairs
- Compliance audits as per current and updated statutory Pharma regulations
- GAP Analysis/ Due diligence
- Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms
- Site Master file as per PIC/s & Local FDA requirement
- Quantitative Risk Assessment ( QRA)
- Environment Impact Assessment ( EIA)
- Safety Audits.
- Energy Audits