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Consultancy

Consultancy is a specialized service that provides global solutions for the Life Sciences market, looking for the most efficient way to comply with those requirements set by specific regulations.

With a network of offices to cover worldwide clients, INVICTUS experts from many different fields have a practical view having worked in regulated environments that allow us to provide the right approach to fulfil health authorities requirements.

From the initial concept starting with an idea, to the final approval by national and international regulators, INVICTUS will guide you safely in the whole process.

Concept Engineering

  • Preparation of the following for approval of THE CLIENT
  • Plant layout in accordance with cGMP & WHO Guidelines. (Getting approval from regulatory agencies is in the scope of THE CLIENT)
  • Concept layout of site plan/plot plan
  • Preparation of conceptual plant layouts
  • Preparation of conceptual plant layouts
  • Estimation of Utilities
  • Schedule for internal finishes
  • Man / Material flow diagrams

Detailed Engineering

  • Plot Plan Finalization with all relevant details like storm water drains, Roads etc
  • Prepare Plain Block Model of all Buildings Located on Plot Plan
  • Layout in Architectural form indicating Final Column Locations, Columns Orientation etc
  • Prepare Layout with Clean room Partition
  • Prepare doors and windows schedule
  • Prepare Process Drain Layout
  • Incorporate Process Equipment in Finalized layout
  • Prepare floor finish schedules
  • Prepare elevations of building in AutoCAD Format for Client Approval
  • Prepare site grading plan
  • Prepare yard and sanitary details
  • Prepare specifications
  • Prepare Bill of qty
  • 3D Views of the Facility (Two- options based on Conceptual Discussion)

Turnkey Project Design & Execution

Workplace
Costing
And fit out
Work with a single point of contact who takes responsibility for programming
Space planning
Contracting

Pre – Audit Inspection

  • Active pharmaceutical ingredients (sterile/non-sterile), intermediate and excipient manufacturers
  • Packaging material manufacturers
  • Drug products. Sterile and non-sterile products
  • Medical devices manufacturers
  • Cosmetic and nutritional supplements manufacturers
  • Services suppliers (analytical laboratories, distribution centers, etc.)

Project Management Consultancy

  • Project planning, coordination.
  • Execution to make sure vendors operate in a safe secure, and quality manner to keep your project on schedule and within budget.

Documentation

  • DQ
  • IQ
  • OQ
  • FAT
  • PQ (Assistance)
  • Commissioning Documents

Validation

  • Preparation of Validation Master Plan
  • Preparation of validation protocols for Process Equipment’s
  • HVAC & utility Equipment’s (Boiler, Chiller, Compressed air & gases)
  • Purified water system
  • Format for Design Qualification Document (DQ) to be filled in by vendor
  • Factory Acceptance Test Protocols (FAT)
  • Installation Qualification Protocols (IQ)
  • Format for Operational Qualification Protocols (OQ) and assistance to client for filling up the same\
  • Witness Validation tests for major Equipment’s

Dossier Prepared As Per Ctd Format

Common Technical Document( Product Dossier) is an integral Part of any registration application For Marketing Authorization.

Dossier in CTD Format/ ACTD Format or local country format is submitted to Food & Drug Authority or Ministry of health

Perfect Pharmaceutical Consultants can help you prepare entire technical document for drugProduct registration in various countries all over the world.

INVICTUS Provides following consulting service in regards to Technical Document (Administrative Information, CT Overview, Drug & Product Part /CMC, Non Clinical, Clinical)

Any Other Services

  • Prepare total equipment list in assistance with client
  • Prepare Process equipment list for major equipment for which URS is to be prepared. Conclude the list with Client
  • To Calculate Equipment capacity and obtain approval from Client
  • Based on the approved equipment capacity, Prepare equipment URS and obtain approval from Client
  • Prepare list of Approved makes of Process equipment’s
  • Identify agencies/ vendors capable of supplying the equipment and their service centers or expected tie ups with local agencies
  • Issue enquiry to pre-qualified agencies/ vendors
  • Receive quotations from vendors in duplicates
  • Compare offers technically and commercially
  • Clarify technical points with vendors in order to bring them reasonably at par
  • Recommend Supplier to Client based on techno commercial and Client discussions. (Client will finally carry out the commercial discussions with vendor and finalize.)
  • After receipt of order confirmation from Client, follow up with finalized vendors for machine drawings like plan, Elevation, Utilities consumption and connection details of utility and I incorporate the same in the layout
  • Prepare final equipment layout in plan and utilities required
  • Follow up with agencies for dispatch of equipment to sit

Provider of integrated engineering designs from
concept to commission.

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