Safe and efficient pharmaceutical manufacturing.
The pharmaceutical industry is complex, with a large number of different regulatory frameworks to relate to. Operating in compliance with regulations and laws while also keeping projects moving presents many companies with a challenge, whether they work at laboratories or in production environments.
At Semcon, we have extensive experience of development, quality assurance, optimisation and implementation of processes for medtech and pharmaceutical production. We use our expertise in production development, digital solutions and regulatory requirements to help our clients streamline their operations. When it comes down to it, our job is to make sure people have access to safe, effective products.
We have extensive experience of working with project management, quality and validation for many different clients and in many industries, which means we know what works and what doesn't.
Digital solutions for enhanced quality and safety
We have to devise new validation and quality procedures as more and more elements of the pharmaceutical industry are digitalised. Semcon has extensive experience of streamlining and digitalising production in combination with the expertise required to ensure quality and traceability.
In my view, there is major potential when it comes to combining our data management and analysis expertise with our life science skills. This provides new opportunities to optimise and streamline pharmaceutical processes.
Experienced life science experts
Many companies may find it difficult to know how best to navigate their way through complex requirements and regulations. Getting help and support from someone who’s dealt with exactly the same kind of problems elsewhere creates a sense of security. At Semcon, we have senior life science experts who provide support in the following areas:
- Quality assurance (QA)
- Quality control (QC)
- System and process validation
- Interpretation of regulations (i.e. ISO13485, MDR)
- Internal inspections and audits
- Establishment and maintenance of QMSs (quality management systems)
- Data integrity (Part 11)
- Process validation
- Project management
- Risk management
Life Science training courses
We also offer a number of popular training courses focusing on GMP regulations, validation and CE marking, among other things. Our experts stay abreast of the latest technology and regulatory frameworks so that we can always remain at the cutting edge of the industry.