ENGINEERING SERVICES TAILORED FOR PHARMA INDUSTRIES

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

TRUSTED BY SOME OF THE TOP PHARMA AND LIFE SCIENCE COMPANIES

INDUSTRIES

Medicinal Cannabis

We are leaders in helping our clients establishing, developing and maintaining a Medicinal Cannabis Business.

 

Pharmaceutical & Veterinary

Stepwise helps Pharmaceutical and Veterinary manufacturers to comply with National, EU, US FDA GMP and PIC/S GMP regulatory requirements.

 

Cosmetics and Food Supplements

We assist you in the compliance with applicable regulations and in the regulatory submission of your products.

Medical Devices

Stepwise can assist implementing Quality Management Systems in medical device companies, compliant with ISO 13485:2016 and/or FDA QSR 820.

 

SERVICES

Market Analysis and Financial

We support our costumers to identify the target markets, stakeholders, products and services for each business and also in the definition of theirs business and financial strategy and model.

 

Licensing

Stepwise can assist you and your company to apply to all licenses required for your Pharmaceutical or Life Science project.

Quality Assurance

We assist our customers from Research and Development (R&D) to Commercial manufacturing following the eight pillars of quality assurance.

 

Pharmaceutical and GMP Consultancy Engineering

Conceptual Design, Front-End Engineering Design (FEED) study, Detail Design, Procurement and Construction (EPC) in a  Turn-key model, are just examples of what we can provide you.

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.

We have the perfect team to ensure that critical compliance issues are a prior for every project.

CQV

We provide a full range of commissioning, qualification and validation services assuring that your facility, equipment and utilities comply with applicable regulatory requirements.

 

Human Resources and Training

When your company is short on staff or resource-poor, Stepwise can help you find temporary or permanent staff. Stepwise provides GxP training courses, both standardized and customized for the companies’ needs.

Regulatory Affairs

Stepwise assists a wide range of industries in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of products for all stages of development.

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