Engineering Services tailored for Pharma industries

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Services provided by Stepwise:

Applications for Licenses to Cultivate and Manufacture Medicinal Cannabis

Two manufacturing licenses will be required to cultivate and manufacture Medicinal Cannabis in its Final Dosage Form. Stepwise can help you granting these licenses.

Front-End Engineering Design/Facility Enhanced Design Review

Our pharmaceutical facility design architects and cleanroom validation, testing and processing engineers are experts in assisting cultivators and Medicinal Cannabis manufacturers with environmentally-minded designs for efficiency and GMP compliance.

Alternatively, if you already have a facility design, we can provide an independent GMP review to make sure that all the important details are covered and nothing has been missed before the property lease is signed and the cement is poured.

GMP Compliance

Stepwise consultancy services for Medicinal Cannabis can help you achieve regulatory compliant processes. These quality management strategies help to ensure that your quality-tested pharmaceutical products are suitable for the markets you aim to serve (meeting EU GMP and FDA requirements and other industry-specific regulatory standards).

GMP Project Management

Stepwise offers GMP project management services to help you get a project up and running as well as compliant with the relevant regulations.

Commissioning, Qualification and Validation Services

We provide full range of commissioning, qualification and validation services – from commissioning of facilities, utilities and equipment all the way to facilities, equipment and computer systems validation, passing through cleaning and process validation.

Quality Management System

Stepwise offers a range of services and products aimed at delivering Quality Management System compliance for Medicinal Cannabis licensed producers.

GMP Contractors

To assist our customers when they are short on staff or resource-poor, Stepwise can help you find temporary or permanent staff with the specific technical skills and experience that you require to move forward.

Financing approval support

Stepwise can assist you in preparing your own data room for sharing with banks or other sources of financing and assist you in the preparation of all the required documentation (business plans, facility design, licensing, etc.).

About our Services

Stepwise offers a wide range of solutions to Pharmaceutical and Life Sciences industries to facilitate Good Manufacturing Practices (GMP) compliance, deliver cost-effective facilities and enhancing operational efficiency.

Stepwise can assist companies to set up their manufacturing facilities from scratch, i.e. from the initial designing and building of the facilities all the way to setting up document management systems, validating equipment, starting production and achieving GMP compliance.

Stepwise provides services to Life Sciences companies such as:

If your Life Science company is not listed above, please contact us to enquire for services.

Support to Cultivation and Manufacturing of Medicinal Cannabis

Stepwise can support Medicinal Cannabis companies to set up cultivation and manufacturing processes:

 

Cultivation (GACP):

  • Propagation, germination (seeds) and cloning stages
  • Vegetation stage
  • Flowering stage
  • Harvesting stage
  • Primary processing (munching and trimming) stage

Manufacturing (GMP):

  • Drying and milling stages
  • Extraction and purification stages
  • Filling, capping and labelling stages
  • Warehouse and dispatch stages

 

Sobre nós

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Services

Medicinal Cannabis

Stepwise can assist you with licensing applications, facility design, medicinal cannabis processing and regulatory requirements for GACP, GMP, PIC/S and FDA. 

Pharmaceutical & Veterinary

Our pharmaceutical facility design architects and cleanroom validation, testing and processing engineers are experts in assisting pharmaceutical manufacturers with environmentally-minded designs for efficiency and GMP compliance.

Cosmetics

When you are building a new facility or refurbishing an existing one, it is important to have the plans independently reviewed to ensure that they meet current Cosmetics GMP requirements.

Medical Devices

Stepwise can assist determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.

What We Do

Stepwise’s services differentiate from other engineering companies by being tailored for the highly GMP-regulated pharmaceutical and life sciences industries. 

The entire pharmaceutical and life science industries manufacturing lifecycle is supported by us helping to set direction, assessing benefits of strategic investments and optimizing manufacturing and business processes.

We assist our customers from Research and Development (R&D) to Commercial manufacturing.

Our goal is to help our customers to achieve and maintain GMP manufacturing excellence and assist them in the route to market.

Industrias

 

  • Blood e tissue
  • Cosmetics
  • Medical
  • Veterinary Medicine

Serviços

 

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Serviços de auditoria

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GMP technical

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Validação

Medical cannabis

 

Engineering

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Engineering

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Engineering

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Contactos

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