We guarantee sustainable added value thanks to:
Expertise in GMP-compliant project implementation
We realise technical projects fully in line with the applicable Good Manufacturing Practices (GMP). From cleanroom design to equipment validation, our approach is aligned with the strictest quality requirements in the industry.
1
Integration of engineering and regulatory compliance
We combine technical project management with in-depth knowledge of regulatory affairs, enabling projects to proceed faster and without compliance risks. This reduces the likelihood of delays in audits or submissions.
2
End-to-end support within the product life cycle
Support at all stages of the product life cycle - from early-stage development to commercial production. We bring technical expertise in process development, technology transfer, validation and continuous improvement.
3
Support in CAPA, change control and deviation management
Our consultants are familiar with the operational quality processes within pharma. We support deviation investigations, root cause analysis, CAPAs and setting up robust change control processes.
4
Strong focus on validation and qualification
Our specialists have extensive experience in equipment qualification (IQ/OQ/PQ) and validation, process validation (PV) and computerised system validations (CSV). We provide fully documented and compliant validation processes.
5
Up-to-date knowledge of sector trends and technologies
We follow the latest developments in Annex 1 (Contamination Control Strategy, CCS), Quality Risk Management (QRM, ICH Q9), continuous manufacturing, PAT (Process Analytical Technology), digitalisation and data integrity, among others. This is how we help customers to optimise in a future-oriented way.
6
Challenges in
Pharma
The pharmaceutical sector faces complex and rapidly evolving challenges. Stricter and constantly changing regulations, pressure on time-to-market and increasing technological innovation require both agility and specialist knowledge.
In addition, labour market shortages, complex supply chains and higher sustainability and data security requirements put extra pressure on organisations. Companies not only have to comply with strict guidelines from EMA and ICH, among others, but also have to invest in talent, efficiency and future-proof solutions.
Select Projects supports companies in this challenging context with customisation, expertise and a people-focused approach - from development to compliance.
From engineering to full compliance
Select Projects stands out in bringing together the right talent and desired expertise, in close cooperation with our customers.
Our team of specialists realises, optimises and maintains high-quality processes and projects in the following areas:
Project Engineering
Your partner in project-based engineering solutions.
Commissioning & qualification
Reliable delivery of critical systems in Life Sciences.
Validation
From strategy to implementation: we take care of the entire validation.
QA/QC Compliance & regulation
Reliable compliance expertise for a regulated world.
In-depth expertise in GMP environment
Proven experience with complex projects within GMP regulations and knowledge of inside requirements.
End-to-end lifecycle support
From early-stage development to commercial production, we support at every stage with the right technical profiles, tools and processes.
Synergy between technology and compliance
We combine engineering strength with in-depth regulatory knowledge and realise projects faster and with less risk of delays or non-conformities.
People-centred approach
We invest in long-term customer relationships and build bridges between people, processes and objectives.
