Service

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, MIES 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, MIES 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
  • 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

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

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.

MIES 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