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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