Feasibility Studies

Spectrum can provide its customers with a complete feasibility study comprising of :

• Market Study
• Technical Study
• Financial Study

The studies conducted will rely on both primary and secondary data, which will involves both desk and field works. Accordingly, the typical approach employed for such studies include -

• Preliminary assessment and study design
• Data collection
  • Secondary data collection
  • Primary data collection
• Assessment of the business environment
• Assessment of the performance of the local pharmaceutical sector
• Supply analysis
• Present effective demand
• Demand forecasting
• Competitor analysis
• Market share analyses and recommendations on product mix
• Pricing and distribution
• Promotion and marketing strategy

The following information if available in advance shall help in developing a more site appropriate design.

• Site Master Plan (if already available)
• Soil Investigation report
• Meteorological data

If the site is not yet identified, SPECTRUM will assume a shape and size of the land and commence development of the designs.

The steps would generally follow the following sequence :

• Computing daily production capacity for each dosage form
• Converting the daily production requirement in the form of required list of equipment and their capacities
• Developing layout plans and sections for the facility
• Developing Site Plan for the entire development
• Developing Men-Material Flow Concepts, HVAC Design Concepts and Hi Water Generation Concepts based on the finalized layout
• Preparing Project Cost Estimates

Based on the technical data such as production capacity and program, cost of raw materials and utility, cost of machinery and equipment, cost of building and civil work, etc., financial analysis of the project will be carried out.

The financial analysis shall comprise preparation of the following :

• Estimated investment costs broken down into fixed investments, working capital and pre-operational expenses
  • Fixed investments shall consist of cost of land, plant and machinery, buildings, tracks and vehicles, office furniture and equipment, and water and power supply and other cost relevant to the project
  • Working capital requirement will be computed based on explicit assumptions regarding, work in progress, cash balances, inventories, prepayments, receivables and payable. The number of days required for the above variables will be determined in consultation with the Client
  • Pre-operational expenses cover costs of project studies and investigations, project engineering and management, manpower recruitment and training, and final commissioning of the expansion project upon completion
• Terminal values to be recouped by the end of the assumed project life will be estimated
• Financial plan of the project will be drawn. The ratio of debt to equity capital will be also be indicated and an amortization schedule for any bank loan that may be taken out to finance the project will be work out
• Operating costs including costs of raw materials and packaging, salaries and wages, labor benefits, insurance, depreciation, repair and maintenance, power, fuel and lubricants, stationery, telephone and postage, etc. will be estimated
• Detailed breakdown of sales quantity and revenue by type of product for each year of the project life shall be estimated
• Profit and loss statements for each year of the project life will be Prepared
• Discounted cash flow analysis, net present value (NPV) and internal rate of return (IRR), financial ratios including interest coverage and debt service will be carried out
• Year-end balance sheets for each year of the project life shall be prepared
• Financial and efficiency ratios will be calculated
• Cash flow tables for the years of the operating period will be prepared
• The break-even point of the project shall be determined
• The impacts of adverse changes to some selected parameters such as selling price, fixed investment and cost of products on the financial performance of the project will be tested through sensitivity analyses
• Impact of the project to the national economy in terms of foreign exchange saving, income tax base expansion, and linkage effect with other sectors of the economy shall be indicated

Technology Sourcing

SPECTRUM, thru its vast network of technical associates and experts, can help its customers in sourcing technologies for various APIs, Biotech Products and Finished Dosage Formulations.

The typical steps followed in technology development and transfer are outlined below :

The scope as a package will typically include :

• Literature search
• Intellectual Property Evaluation
• DMF related NON INFRINGING Processes
• Development and validation cost
• Lab validated process
• Analytical methods for RM
• Specs of RM and Intermediates
• Final product and In-Process checks
• Method development, method validation
• Lab DEMO
• Plant demo

Technical Due Diligence

Parties looking to acquire existing pharmaceutical set ups can avail services of Spectrum to assess the current conditions.
The assessment can be conducted to cover the following :

• Review of Capacity and product mix of exiting production set-up
• Review of exiting Utility set-up
• Major GMP regulatory compliance issue issues with respect to current facility infrastructure and the documentation practices
• Scope for future expansion / capacity increase within the plot boundary
• Estimated cost of existing plant and machinery
• Any other issues related to facility acquisition

cGMP Auditing

Spectrum can audit existing and or new facilities to conform their compliance with the current GMP Standards of local and International Regulatory authorities viz:

• Australian TGA
• Brazil ANVISA
• EU GMP
• Indian Schedule M
• PIC/s
• South African MCC
• UK MHRA
• US FDA
• WHO
  

Spectrum can also recommend measures to upgrade existing facilities to meet the above standards.