Medicinal Cannabis European Market Overview
Europe is set to become the world’s largest legal cannabis producer reaching a market value up to € 123 billion by the end of 2028.
Medicinal Cannabis Regulatory Framework in Portugal
The use of Medicinal Cannabis for therapeutical indications was approved in Portugal on July 15, 2018, regulated by the Law nº33/2018.
This triggered an exponential investment in cultivation and manufacturing of medicinal cannabis in Portugal.
Why to invest in Portugal?
The medicinal cannabis’ market is becoming more and more competitive, and Portugal is the perfect bet when choosing the place to grow, manufacture and distribute medicinal cannabis with its:
- Propitious day light exposure and water availability
- Cost effective land, labour and resources
- Highly skilled workforce and vibrant research community
How can we support your business?
Stepwise can assist you with licensing application, facility design, medicinal cannabis processing technologies complying with regulatory requirements for GACP, GMP, PIC/S and FDA.
Stepwise can provide turnkey Medicinal Cannabis facility design and construction (Engineering, Procurement and Construction – EPC). Our approach to the facilities design targets specifically for success intending to optimize efficiency and compliance. Stepwise’s approach to facilities design for cultivation and manufacturing, uses Lean Manufacturing principles to help clients achieving their full operational potential.
Stepwise’s range of services covers also Regulatory and Marketing services to assist clients in the route to market.
- Site Property Procurement
- Business strategy and model preparation
- Cultivation , Import & Export and Wholesale License applications
- Recruitment of Technical and Security Director
- Define your cultivation technology across all cultivation’s stages
- Define and optimize your cultivation schedule to achieve highest yields per year
- Design your cultivation facility
- Standard Operating Procedures and Work Instructions
- Support the recruitment of master growers
- Preparation of GMP Manufacturing, Import & Export and Wholesale License applications
- Support the recruitment of a Qualified Person and Security Director
- Design your manufacturing facility using lean manufacturing strategies to meet applicable GMP regulations
- Commissioning, Qualification and Validation (CQV) of manufacturing facilities
- Development and preparation of product specifications
- Preparation of the Quality Management System (QMS)
- Execution of internal, external and supplier audits
- Cannabis strains selection
- Support and management of R&D cultivation genetic development
- Scale-up from the laboratory to commercial batches applying Quality by Design (QbD) principles
- Development and Validation of analytical methods
- Design and development of a licensed laboratory facility
- Identify qualified third parties’ laboratories to support operations
- Management of stability studies
Support in supplier selection and qualification