Consulting
Services
Background:
At AmTech, we draw on 40+ years of experience in the areas of research, production, and marketing management to provide our clients with the greatest possible return on investment while providing noticeable competitive advantages. Our extensive domestic and global contacts can provide collaboration for management and technological venues, increase business development and provide extensive sourcing of raw materials / ingredients to reduce costs. From Concept / Formulation to Production to Sales & Marketing, AmTech covers all aspects of business: Operations, Regulatory (QC, QA, SOP, GMP, FDA Licenses) and Marketing (including pricing, establishing sales network, direct or through broker / distribution channels).
Primary Services:
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· Facilities Start Up |
· Technical Writing | · Operational Management |
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· Regulatory Approvals & Laisons |
· SOPs | · Validation |
| · Product & Process Development | · Patent Searches | · cGMP |
| · QA Audit | · Raw Material & Equipment Sourcing - Costing - Qualifications | · Label Review |
| · DMF / DSHEA Regulations / ANDAs | · Sales Management via broker or distributor / & other methods |
Value Added Services:
We help you identify the most profitable strategy for your unique strengths, formulate a plan of action, provide support to your in-house resources as required, help achieve the desired objectives and provide support in managing technical, regulatory, and business management.
Our Broad Range of Client Services Include:
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· Organizational Effectiveness Assessment
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· Compliance: Regulatory Affairs, Labelling, Recall Procedures, Audits, ANDAs, DMFs, cGMP, SOPs, and Validations
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· Facility Design: Building Layout, Equipment Selection and Qualifications, Laboratory Operations, Auditing during construction and installation phases, Approvals with the necessary Regulatory Authorities.
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· Research & Development: Dosage Form Design and Improvements, Process Development & Equipment Selection and Optimization, Process Improvement, Technology Transfers, Scale Up from R&D to Manufacturing and Marketing, Relevant Documentations |
Example - Process Development:
On an Anti-fungal cream with one of the major pharmaceutical companies, we provided a process technology solution which prevented heavy rejects and thereby provided substantial cost savings.
For a multi-national, multi-million dollar product, improvised the client's total manufacturing process, starting from raw material sourcing to tablet compression, providing more than 50% cost savings to their manufacturing cost.
Example - Regulatory:
One of the major pharmaceutical companies had a product recall by the FDA due to the stability of the product. We implemented a packaging solution for the product which solved the stability problem. This allowed re-introduction of the product in a very short time.
Have responded on regulatory complaints of FDA for various companies relating to the compliance with reference to SOP and Labeling Deficiencies and saved recalls for the companies.
Example - Sales Management:
Have introduced few nutraceutical ingredients and natural fibers for an overseas ingredient manufacturing company to the U.S. We established DMFs and conducted audits for quality approvals with large food and pharmaceutical manufacturers. Company exceeded $10 Million sales iwthin 1 year time.
In the beginning of 1990's, U.S. had an increased trend of fat free and weight loss products in the market. We developed and provided a unique product to the marketer which monopolized the market and the industry grew extensively with the trade name of that product.
PO Box 33, Piscataway, NJ 08855
Tel: 732.365.0550 Fax: 732.885.1235
Email: Amtechresources@yahoo.com