Quality Validation & GxP Pharma & Biotech2020-08-12T09:56:51+00:00

Quality, validation & GxP in the pharma and & biotech field

The pharma and biotech industry provides pharmaceutical products for patient care, whether for home care or hospital use.
Because such products are used to treat humans and farm animals, and in a sensitive and non-optimal physiological state, using invasive procedures, this industry places a particularly high level of risk and is characterized by stringent levels of supervision and regulation, to maintain public health while minimizing risk and risk. In human life, however, that will enable the delivery of beneficial and high-quality medical products that will enable continuous care.  

The quality field and GXP dominate all processes involved in the production of pharmaceutical products, from supplier selection and raw materials, through development, production, packaging, quality control, and storage to the conveyance and distribution of the product to end customers.

What customers think of us

Quality, validation & GxP consulting in pharma & biotech

  • Basis of Design writing and approval in relevant health authorities

  • Pharmaceutical quality management system establishment

  • Master documents, policies and procedures writing and training

  • Facility & laboratory conceptual design based on regulation

  • Risk analysis and risk assessment

  • QP services

  • QPPV services
  • Compliance with the Israeli ministry of health  126 & 130 guidelines

  • Internal audit, gap analysis & training towards Eu/FDA inspection

  • GMP audits and GMP consulting

  • Quality, clean rooms, risk management and validation training

  • Annual GMP training

  • Data integrity and ALCOA

  • Third party periodical audits and inspections for suppliers, CMOs and laboratories

  • CMC file for IND

  • Quality system improvement projects

  • Regulation and submission

  • Pre-audit readiness

  • ISO 27001 and ISO 27799 certification

  • HIPAA, SOC2 & GDPR compliance

  • ISO 14001, ISO 17015 and ISO 22000 certification

  • Safety & EHS services

  • Validation for clean rooms

  • Validation for equipment and systems

  • Validation for manufacturing and cleaning processes

  • Validation for analytical methods and laboratories

  • Validation for software and control systems based on 21CFR part 11 and Annex 11 requirements

  • Validation for packaging and sterilization
  • Validation for storage and shipping

  • External validation services and contractors

  • External QA services and contractors

  • Project management

Other pharma & biotech services

You are invited to contact us

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