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Amereast Inc.

Pharmaceutical Engineers

Services: We provide consultancies for the following issues: Process and product Development New drug product development- Solid dosage form, liquid dosage form and semi solid dosage form manufacturing according to cGMP principles New medical device development, design and manufacturing according to ISO 13485 (Including 510K) Process development and transfer from research & development to production scale (Scale up) Process engineering and process design Clinical trials batch production according to FDA/CE compliance (including pre-clinical trials) Machinery and equipment purchasing consultancy Pharmaceutical and biotechnological production troubleshooting Biotechnology, pharmaceutical and medical device project management


Our Services Validation    

  

Validation management, validation strategy Validation requirements analysis Validation policy documents (validation master plan, validation protocols, cleaning validation/verification policy etc.) Installation qualification, operation qualification and performance qualification protocols for equipment, manufacturing process and infrastructure Process validation, software validation, computerized system validation and cleaning validation/cleaning verification Validation execution and validation reports Medical device sterilization validation (Steam, heat, EtO, gamma ray radiation) Product's packaging validation Validation protocols inspection Validation training

Quality Assurance      

GMP & Quality assurance compliance A new quality assurance system establishment Quality management Risk analysis and risk management Guidance and preparation towards FDA and CE inspection and approval ISO 9000 and ISO 13485 compliance


         

ISO 9000 and ISO 13485 compliance Documentation center establishement- Procedure and SOP writing GMP training and GMP consulting GMP audits performance Site master file Base of design for new plant/facility Calibration management SOP's- Production, operation, maintenance and safety Training and presentations ANDA writing (A new drug application)

Engineering, Planning, Supervision & Infrastructure 

    

Planning, management and supervision in the establishment of infrastructure projects, plants, production departments and technologies Functional planning for plants and departments including "Basis of design" document and approval by authorities Engineering documentation and engineering procedures Guidance and consultancy regarding clean-rooms and watersystems (Purified water, reverse osmosis and water for injection) Trouble-shooting and improvement of manufacturing technologies Technical and engineering drawings


Pharmaceutical Equipments Amereast Inc. provides proactive asset management services and solutions for large and small corporations in the pharmaceutical, biotech, chemical, and consumer packaged goods industries by providing the highest quality equipments with reasonable prices. Our success in accomplishing this Vision is dependent on our ability to build an intimacy with our customers. We strive to provide solutions and services to our customers in a manner that is superior to any of our competitors by a wide-margin. Our goal is to create a satisfaction level that not only keeps our customers loyal, but also inspires them to tell others about Amereast Inc. and the way we conduct our business. This type of success starts with having all employees across the company passionate about our business. An important element of our employee involvement comes from our unique culture where every Amereaster pledges and dedicates themselves to a set of core principles:      

Being customer-focused and exceeding expectations. Promoting a non-political, professional environment by treating everyone with honesty and respect. Rewarding employees based upon the value they create for customers and shareholders. Fostering an entrepreneurial spirit by encouraging employees to constantly search for better solutions. Accomplishing our set goals through teamwork. Being fair and consistent in everything that we do.


Pharmaceutical Equipments Amereast Inc. has chosen to focus on companies in the process and packaging industries. The experience of our employees within these industries gives us a better understanding of our customers and helps us constantly innovate and advance our capabilities. These factors coupled with the fact that every Amereaster’s compensation is tied to how well we meet and how satisfied our customers are in our management of their projects and programs.           

  

Documentation center establishement- Procedure and SOP writing GMP training and GMP consulting GMP audits performance Site master file Base of design for new plant/facility Calibration management SOP's- Production, operation, maintenance and safety Training and presentations ANDA writing (A new drug application) Engineering, Planning, Supervision & Infrastructure Planning, management and supervision in the establishment of infrastructure projects, plants, production departments and technologies Functional planning for plants and departments including "Basis of design" document and approval by authorities Engineering documentation and engineering procedures


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