Engineering, PM, HR, IT

  • Engineering, design, turn-key solutions of EU GMP compliant manufacturing sites and QC laboratories,
  • Project Management, HR and recruiting services
  • IT solutions for pharmaceutical companies
  • Legal advising and corporate legal/administrative consulting services with licensed partners
  1. Turn-key Solutions in Manufacturing Sites Development
  • Conceptual design/solution
  • Feasibility Study including Business Case development (full set covered - market research, defining detailed product list of products that will be manufactured/distributed, identification of resources available at investor, research and evaluation of existing capacities and resources, identification of potential global sources of knowledge, technology and supplies, identification of potential cooperation partners/sources of technology and registration dossiers, research for the outsource services and support in QC, PQS and RA, estimate of expenses, forecasts of production and sales, profitability analysis, budget definitions and funding development, definition of steps/stages of the Project realization)
  • Full support in designing, setting up, construction or adaptation, building, technology definition, equipping, staffing and realization of the project realization
  • Full support in selection, contracting, negotiations, equipping and realization of production equipment
  • Turn-key services in designing, building, equipping and realization of the QC laboratory
  • Full support in selection, contracting, negotiations and establishing of the legal framework for potential partners, suppliers
  • Turn-key solution for construction of the new facilities/refurbishing of existing in order to set up selected product list in manufacture
  • Full support in technology transfers & Analytical methods transfers (Know-how transfers) for chosen products and support in Regulatory Affairs (re-compilation of registration dossiers) and registration procedures worldwide
  • Full support in developing of the FDA - EU GMP level compliance of manufacturing capacities as well as in FDA/EU certification of the plant
  • Full support in strategical marketing in regional, WHO and global markets.
  • Full support in management of the Project as the long-term strategical investment.
  1. EU GMP QUALITY MANAGEMENT SYSTEM DESIGN, SET UP AND IMPLEMENTATION OF TURNKEY SOLUTIONS IN MANUFACTURING SITES DEVELOPMENT
  • Project Management (GMP compliant) setting up the system, training and documentation management/archiving set-up - as per ISPE Good Engineering Practice (GEP) Guide and ISPE Good Practice Project Management (GPPM) for Pharmaceutical Industry Guide, support during Project realization
  • Verification of PM/Engineering Documents compliance to GMP and Good Practices in Engineering and PM (People management, Risk Management, Project Initiation, Project Deliverables, Design, Specifications - URS, Procurement, Construction, FAT/SAT and Commissioning, Maintenance, Validations, Operations, Project Close-out)
  • Set up QMS, implement it (SOP writing, trainings, certification)
  • Set up legal framework with suppliers of bulk/technology and dossiers
  • Manage Technology Transfers and Analytical Method Transfers
  • Verification of all the above – set up complete documentation
  • Process Validations
  • IT solutions
  • Set up local and/or EU batch release system
  • Set up the factory operative
  • EU mock-up, voluntary GMP audit and report by independent EU expert
  • Local and/or EU GMP certification and Manufacturing License
  • Local and/or EU dossier development and compilation
  • Local and/or EU marketing authorization process, including complete pre- and post-marketing authorization support
  1. LABORATORY ENGINEERING, DESIGN AND CONTRACT ANALYTICAL METHODS DEVELOPMENT
  • Projecting, planning, design and consulting in the scope of establishment and development of the medicines quality control (QC) analytical laboratories and medical diagnostics laboratories.
  • Consulting activities intended to support planning and purchasing of equipment and consumables for analytical laboratories.
  • Turn-key services in designing, building, equipping and realization of the QC laboratory
  • Consulting and supporting activities in the scope of analytical methods development, transfer and validation. Realization of analytical method development including training of staff for developed methods.
  • Consulting in the scope of organization (and re-organization) of laboratory services including development and implementation of information management laboratory structures.
  • Set up QMS, implementing (SOP writing, trainings, certification)
  • EU mock-up, voluntary GMP audit and report by independent EU expert
  • Local and/or EU GMP certification and QC lab licensing
  • Medical laboratories accreditation support
  1. HR & RECRUITMENT SERVICES
  • Advising management on the administration of human resources policies and procedures
  • Setting-up HR Department and organizational structure of the company (Organigram)
  • Analyzing a company’s current HR programs and recommending solutions
  • Developing, revising, and implementing HR policies and procedures
  • Ensuring HR programs and services are in compliance with established policies and procedures, GMP standard and local laws and regulations
  • Preparing and maintaining reports related to specific HR projects
  • Assisting with the development and coordination of recommended changes regarding workflow
  • Developing methods for compiling and analyzing data for reports and special projects
  • Conducting audits of HR activities to ensure compliance
  • Presenting training sessions related to specific HR programs
  • Full support in recruitment and hiring procedures including writing job descriptions, planning to hire, writing job advertisements, Posting the Job and Screening Incoming Resumes, Setting up Interviews and Conducting Post-Interview Assessments, psychometric tests and interviews, technical interviews, candidate selection procedure, determining compensation and benefits of the position, extending the job offers, negotiations with candidates, contracting, defining the new employee processes.
  • Consulting with management and supervisors to stay current on organization policies, procedures, business initiatives, technologies, and regulations
  • Coordinating corporate training programs with hiring and training periods and events
  • Formulating curricula and instructional delivery methods as to accommodate hiring and training requirements
  • Overseeing the creation and development of instructional training methods, such as individual training, group training, lectures, demonstration, conferences, and workshops
  • Selecting teaching aids that assist in training, such as handbooks, demonstration models, multimedia visual aids, webinars, and computer tutorials, among others
  • Testing trainees as to measure progress and effectiveness of training programs
  • Reporting on employee training progress to department management and supervisors
  • Maintaining accurate training records
  • Receiving feedback from employees regarding effectiveness of training methods
  • Team Building services
  • Employee Assistance Plans development and consulting
  1. IT SOLUTIONS & COMPUTERIZED INFORMATION SYSTEMS
  • Development, projecting, planning and consulting for realization and implementation of computerized information systems (networks and software) in pharmaceutical sector.
  • Realization of such systems (based on our projects) using contracted specialized hardware and software companies. Vendor developed databases and applications for pharmaceutical industry, regulatory authorities and health care institutions.
  • The systems for public and hospital pharmacies, retail services, wholesalers and distributors, importers, exporters, representative offices, manufacturers of herbal drugs and medicinal devices, medical services, warehouses and complete pharmaceutical industry could be covered under this point.
  • Consulting for the planning and realization of purchases of computerized information systems.
  • Projecting, planning and consulting for realization and implementation of LIMS structures (Laboratory Information Management Systems) in laboratories: medicines QC, biochemical, chemical, toxicology, eco-toxicology, etc. Realization of such systems (based on our projects) using contracted specialized hardware and software companies. Ready-to-use applications available for biochemical, clinical chemical, molecular biology laboratories and for laboratories for QC of medicines.
  • Verification and qualification of present (installed) computerized information systems.
  • Organization and realization of training courses in the scope of computerized systems applications for pharmaceutical sector and in the scope of LIMS applications.
  • Support in designing of the complete IT networks (hardware, net and OS)
  • VPN networks designing, VOIP solutions, communication hardware and software, internet solutions, intra-company cloud solutions designing and provision
  • Support in defining URS, designing, selection, purchase and installation of the complete IT software solutions for pharmaceutical industry (SAP, ERP, LIMS, RA, PV, DocM, EBR, Process management, etc.)