Pharma & Biotech R&D2020-08-12T09:55:22+00:00

R&D in the pharma & biotech field

Pharma and biotech researchers are engaged in the development of active substances, pharmaceuticals, microorganisms, human cells, viruses (whether genetically modified or not) and other biological substances such as peptides, hormones that may be used as drugs or therapies

The development process will include characterization and review of materials, modeling, initial formulation, preclinical trials, production trials, manufacturing and pilot engineering, and the development of advanced manufacturing technologies for clinical and commercial production purposes per various health authorities’ guidelines such as the FDA and GMP standard.

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R&D consulting services in the pharma & biotech field

  • Biotechnological, pharmaceutical & biological product development

  • GMP pilot and small-scale development processes design

  • Biotechnological and pharmaceutical manufacturing processes engineering and design

  • Clinical batch manufacturing according to FDA & Eu. regulations

  • Manufacturing, engineering and technology consulting

  • Biotechnology and pharma process troubleshooting

  • Troubleshooting cleaning and contamination issues

  • Clinical trial plan and protocols

  • Laboratory and clean rooms design

  • CMC  writing

  • Preparations towards external audit

  • Employees training

  • Patent application consulting

  • GLP and ISO 17025 certification for laboratories

  • Pilot batch manufacturing

  • Product and patient risk analysis and risk assessment

  • Stability studies protocols and testing

  • Development reports writing

  • Biotech and pharmaceutical development projects management

  • Business plan and presentations for investors and funding

  • Investment & funding strategy

  • Product development and commercialization strategy

  • Development and global regulatory strategy

  • Product market analysis

  • MSDS writing for new DS and DP

  • Laboratory safety and EHS services

  • Documentation, procedures and training based on GLP

  • Laboratory quality management system and training

  • Preparations towards due-diligence

Other pharma & biotech services

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