Newage Pharma offers a system of complex project management, including recommendations at a step of the search and estimation the idea to a step «ready-to-start production facilities» and subsequent follow-up. Pharmaceutical engineering is involved in the conception, design, scale-up, manufacturing, labeling and packaging processes in the conversion of chemical and biological materials into valuable pharmaceuticals.
The key to success is in the effective management of the project and updating the information about pharmaceutical engineering and closely related industries. Methods of technology transfer refer to the processes of successful progress from drug discovery with application of flexible logic models, up to the clinical trials and ultimately full-scale commercialization.
Scope includes review of the acceptability of the stability study of the finished product, determination of action plan in case of failure of stability studies
Engineers provide technical support to enable technology transfer and address technical issues with local manufacturing groups. These groups are also involved in process engineering and work to improve and expand existing pharmaceutical processing systems. Our capabilities in technology transfer projects include API development and manufacturing, formulation development, analytical development and testing services, and stability.
Research and Development is the driver of innovation and leadership. This is the way to experience future growth and develop new products or processes. Newage Pharma team of experts has built an impressive track record of successful projects and constantly work to bring out products with appropriate technology and features to meet the changing customer needs. The scope of R&D services includes generation of patent landscapes for molecules under development, identification of patent non-infringing approaches for patented molecules, opportunities identified as Para-IV candidates, increased rate of Bioequivalence success. The development reports provided are based on FDA, EU requirements(ICH Q8/QBD).
Company’s performance edge is based on offering Quality-By-Design (QbD) concepts at all stages of formulation development. The Design of Experiments (DOE) along with relevant time scale and risk assessment helps to develop the strategy for further experimentation.
Newage Pharma has a wide R&D experience:
Dosage forms handled:
Product technologies handled:
Process technologies handled:
Newage Pharma provides assistance to pharmaceutical companies to achieve their priority regulatory milestones, to ensure the effective movement of the product through the regulatory process. The company provides data monitoring and analyzes it in the appropriate context; and generates a meaningful output with the designation of the risks and opportunities for the client’s strategy on the issue of regulation. All the process of the regulatory support is based on the business needs and is linked to the decisions and actions.
The company offers full cooperation and assistance in the process of preparing CTD format on all modules, which are intended to be common for all regions. We provide regulatory support in Eastern Europe and the CIS countries for the manufacturing of pharmaceutical products from generic drugs to biotech products including Bioequivalence studies and clinical trials. Extensive expertise and experience allow us offer the following range of servies
Newage Pharma Consulting offers validation and compliance services to the pharmaceutical and related industries, including audit object, assess the client’s current state of production to meet the actual requirements of GxP quality standards. Facility Audits and Validation Service include checking of equipment qualification, technical and engineering systems, which should be verified according to structured and documented procedures agreed with the client. The company offers a comprehensive suite of validation services of production and design facilities approved by validation experts that fully meet international standards, such as checking and preparation of documentation on possible process deviations and/or discrepancies. The audit activities are focused on risk analysis and what is critical to the quality of the final product. The company’s specialists provide recommendations for the necessary changes or alternative solutions needed to address the identified problems, such as development of a balanced certification strategy and validation master plan.
Newage Pharma is working in the area of provision of patenting services and support to wide range of companies for filing patents, domestic and internationally, as well as help start-up companies using technology licenses from universities and other research centers, with major activities including:
Patent Search for clients to ascertain the novelty of their inventions.
Check of Patent Expiry Status Report Worldwide to determine expiry terms for a given patent in a specific country or world-wide.
Patent Mining Services for R&D Coordination
Preparation of Freedom to Operate Opinion and recommendations on product or technology clearance for avoidance of potential infringement.
Consultancy on Patentability requirement of customers’ inventions.
Customized World-wide Patent Watch on individual Patents / Patent Applications or field as a whole, including infringement–related surveillance.
Filing, Prosecution, Maintenance and Enforcement Services for Trademarks, Copyright & Designs
Patent Filing & Prosecution Services, national and international (PCT) applications
including preparation of prosecution templates, replying office actions and sending reminders of upcoming due dates.
Patent Specification & Claims Drafting in accordance to national law and PCT.
Pre-Grant and Post-Grant Opposition drafting and filing
IP Audit & IP Portfolio Services including creation, maintenance and tailor-made IP solutions
Newage Pharma also helps the clients to identify and seize opportunities as well as diffuse threats to their intellectual prosperity thanks to unrivalled ability and experience over established firms.
Peter Senge (1990:3) described learning organizations as:
«…organizations where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together.»
Seeing the «whole» as regards GxP is imperative and will keep organization on track with existing rules as well as emerging ones.
Companies implementing GxP are performing a regulated process that is most likely linked to a predicate rule or guidance and should be covered by policy and/or specific documented procedures (a.k.a. SOPs). Newage Pharma has an extensive expertise and provides services for qualified staff recruitment, training and coaching. The advantages of cooperation include:
Below is the tentative list of general courses offered by the company. Extended programs and individualized programs shall be considered based on customer’s requests and needs.
Environment, Health & Safety
Quality Management System
Validation & Qualification
Training for Clean Room Operations, Equipment Handling and Documentation Activities.
Procedures for Operation, Cleaning and Preventive Maintenance.
Procedures for Environment Monitoring,
Procedures for Calibration of Master Instruments and Process Instruments.
Calibration Schedules –Equipment wise.
Procedures for Operation, Cleaning, Sterilization, Disinfection, Sanitization & Monitoring.
Procedures for Gowning & De-Gowning.
Procedures for Personnel Hygiene Monitoring and control.
Procedures for Area Monitoring and control.
GLP System and testing.
Review of Instrument Qualification Protocols & Monitoring of Commissioning Activities.
Instrument Calibration Schedule and Monitoring of Calibration Activities.
Procedures for Testing Activities of Water, Nitrogen, Raw Materials, In Process Material, Packing Material and Finished Products.
Procedures for Testing Activities of MLT/ Bio burden in Purified Water, WFI, Pure steam, Raw Materials & Product.
Procedures for Testing Activities of BET in Purified Water, WFI, Pure Steam, Raw Materials and Product.
Procedures for Testing Activities of Product Sterility Testing.
Procedures of Media Preparation, Sterilization, Plate Preparation, Exposure Activities.
Procedures of Culture Suspension Activities & Organism Identification.
Standard Test Procedures, General Procedures, Stability Specifications and Other Miscellaneous Test Procedures.
Procedures of Biological Indicator Qualification & Handling.
Procedures of Incubation & Inspection Activities.
Concerned Persons, Monitoring of Execution and Review of Reports.
Procedures for Goods Receiving, Storage, Segregation, Sampling, Dispensing and Issuance.
Procedures for Monitoring /recording of Storage condition.
Procedures for storage of Finished Goods.
Preventive Maintenance of Process Equipment
Preventive Maintenance of Facility
Preventive Maintenance of Utilities (Clean & Black)
Calibration of Equipment