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Services

Todays Pharmaceutical Buisness is at the cross road of a great revolution. With new technologies for better production and with strict competition both from the regulatory bodies as well as from the vast depleting and steadily rising Generic market, the call of the industry is "Best Quality at the Cheapest Cost".

The modern history of small molecule pharmaceuticals started in 1899, when Bayer was awarded the patent for Aspirin®. Since then, an industrial revolution has improved the quality of life for many people by providing access to important treatments of a wide range of diseases.Aspirin which started its career as a painkiller is now a multifacet drug.

Ayurveda and Homepathic treatments which were once considered as Eastern is now a leading pharmaceutical force. Both of these have passed their 'traditional' branding and is the developing force of the pharmaceutical industry. '

Today, many pharmaceutical companies are facing patent expiry of significant products and generic competition is becoming stronger and stronger. The pressure for cost-effective production goes hand in hand with a continued or even increased focus on product quality. The pharmaceutical industry is forced to reinvent itself – through new quality paradigms, more efficient production and more cost-effective supply chains.

The art of manufacturing traditional pharmaceuticals is becoming more multi-faceted, due to the increased diversity of the supply chain of most pharmaceutical companies. New suppliers of raw materials, potential sourcing from contract manufacturers, an increasingly international supply chain, more markets, diversity in batch sizes, different regulations, labelling or traceability requirements are just some examples.

The expiry of patents and the rearranged supply chains represent the end of the ’blockbuster’ era. Innovation-driven pharmaceutical companies are looking into increasingly specialised pharmaceuticals besides their branded generics.

We know that many of our customers see the challenge – and we offer our help in many areas. As a global company, we follow the trends and opportunities of regulations, best practice industry standards and technology through our global network. And more importantly, we offer services locally through our many offices, adapted to your local needs as well as your global challenges.

 

CleanTech has established a consultation philosophy based on sensible, scientific solutions to the complex problems faced by regulated industries.  Our consultation approach involves a

blend of science and engineering, practical and theoretical, which affords us a flexibility and perspective that most companies do not offer.  With industry experienced scientists and engineers, as well as a full-service architectural department, CleanTech can bring unique options to any project.  Our team of experts are recognized leaders in their fields, and stay abreast of technological and regulatory trends

so that we can offer you practical solutions which meet federal and international regulations and guidelines.

Our broad range of services includes:

With extensive experience in the design and construction of pharmaceutical and biomedical facilities CleanTech can handle any project, from the conceptual phase through detailed design and engineering.Our qualified staff is available to provide the services required for project implementation, planning and monitoring.  This includes equipment specification and selection, review of bids, selection of a contractor, project management and related tasks

  • Facility Design and review
  • HVAC and automated systems 
  • Process Design and development
  • Process Mapping
  • Equipment specification, selection , helping the client in negotiation and FAT
  • GMP and GLP compliance audits
  • Validation Master Plans
  • Quality Manuals
  • Training Programs
  • Pre Approval Inspections
  • Process Transfer technology
  • Enviornment friendly designs.

We value the partnerships created when we begin a new project.  Your success is our top priority.   A majority of our business comes from repeat customers – a real source of pride and indicator of our achievements.  At Cleantech, we realize the need to balance your regulatory and business concerns and we work with you to identify and implement solutions which optimize your resources.

We understand that computer automated systems represent an important component of today's facilities.  Meeting federal
regulations has become a complex task that requires staying on top of regulatory trends.  CleanTech’s team of consultants, specializing in automated systems, has a working knowledge of cGMP, GxP and 21 CFR Part 11 regulations and guidelines.  
 
By actively participating in the design and implementation of pharmaceutical processes, we have garnered the knowledge and skill set to ensure the success of our clients.   
With backgrounds and experience not only within Quality Assurance/Quality Control departments, but also management, networking, user support, system administration, office automation, project management and design, analysis, training, and programming, our staff has
facilitated implementation and/or review of QA/QC procedures and created records for critically engineered systems and process equipment.  Our systems are designed to comply with all federal regulations providing our clients with the necessary compliance coverage.  We can design your system and the associated controls and control panels. 

No facility can run smoothly unless all aspects of that facility are installed correctly and operating together.  Our experience with systems, equipment, and process validation is critical to
achieving this coordination.  Our experience is customized to meet your needs, and meet the best practices and regulatory requirements. 
 
 
CleanTech is ready to assist your company by providing Regulatory Affairs consulting, compliance, and auditing services.With special expertise in the submission of regulatory documents and, CleanTech’s diverse team provides the following scientific and technical regulatory affairs consulting
services for its clients to assist them in understanding and meeting the process and procedure requirements of the FDA.
 
 CleanTech Solution provides comprehensive teaching and training programs for virtually all aspects of GxP regulated industries. Comprised of Chemists, Microbiologists, Engineers,
Process Specialists, Quality Specialists and Control Specialists, our team can custom make teaching and training programs for your company’s specific learning needs.
As Scientists and Engineers, we can provide invaluable insight into the inner workings of industry, with specific case studies and experiences involving audits, working with the FDA, process troubleshooting, institution of new technologies, training of operators, and many other fundamental industry interests.
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What company is not ready to take their business to the next level? Everyone is always ready to take that next step, move on to the next project and most importantly make more money!

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