Turnkey Consultancy

EUROPA BIOCARE is a pharmaceutical project management services company promoted by a team of highly qualified and experienced international pharmaceutical experts.

Our range of services covers right from conceptualization and designing of a new plant, as well as existing plant, to its construction, and also setting up manufacturing facilities to its commissioning.

The company's expertise also includes modification or extension of an existing plant with all modern and regulatory aspects. we provide a complete turnkey solution for the pharmaceutical industry, under one roof.

We offers turnkey consultancy services for projects as per WHO, GMP, USFDA, MHRA, TGA and GMP norms and requirements. We are one of the leading pharmaceuticals project management consultancy firms providing turnkey solutions for pharmaceutical, biotechnology, health, food, education and hospitality industries.

We offer professional services to clients’ specific requirements and take pride in providing current top quality STATE OF THE ART ENGINEERING CONSULTANCIES and ERP implementation.

Pre Audit

We assists clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing.

Our consultants will visit the your facility and carry out an inspection in the style of the relevant regulatory body (FDA, MHRA, EMA, Saudi FDA, GCC etc.) after which we provide:

  • An in-depth, impartial and professional assessment of their current state of compliance
  • A detailed, prioritized action plan for the rectification of areas of non-compliance and vulnerability
  • Staff coaching in the sorts of questions which are likely to be asked during the inspection and how best to answer them
  • Sound, practical support and advice in the run-up to the real inspection.

Master Planning

We, at EUROPA BIOCARE enable our clients' business planning efforts, helping them to meet their strategic goals, recognizing opportunities for innovation and providing solutions which provide the basis for success of the project. In all projects the goal should be to find solutions fulfilling basic functional requirements at the lowest life cycle cost. Concept designing and master planning serves as a guideline for basic and detailed engineering development.

Our services under master planning include
  • Site Master Planning
  • Site assessments
  • Concept development
  • User requirements specifications
  • Drawings and Specifications

Facility Engineering

Facility engineering is one of our key services and we have executed several engineering consultancies due to our dedicated focus on the pharmaceutical industry. Study of various alternative schemes to arrive at the most suitable one, keeping in view the functional economical and an esthetical aspect. Preparing machinery layout drawing as per Clients / Process Consultants guidelines. Process plant building, utility block, electric sub-station etc. Preparing architectural plans, elevations and sections for various buildings such as process plant building, utility block, electric sub-station etc.

Our services under facility engineering include
  • Facility design with special focus on HVAC, BMS, Treatment, purification, filtration and distribution of various utility systems.
  • Develop P&IDs for process and utilities
  • Alternative plant layouts meeting cGMP requirements

Installation & Commissioning

Our commissioning and qualification team has the technical skills and experience to make our clients' projects successful. Our team can provide commissioning documents that verify proper installation, operation at start-up, functional performance, and turnover of facilities, systems and equipment. Commissioning services include SAT (Site Acceptance Test), to ensure all systems are supplied in specified condition.

Validation & Documentation

We does not limit ourselves to controlling final project quality, but also works to guarantee it from the previous phases until the final handover to the user. As an integral part of project development, EUROPA BIOCARE executes a complete commissioning and qualification plan, with full documentation that ensures final product quality.

The main stages of this plan include
  • DQ
  • FAT
  • IQ
  • OQ