Commissioning, Qualification and Validation planning and execution in pharma and medical device projects, incl. project quality management, quality risk management, preparation of qualification/validation plans, protocols and reports and supplier handling and audits
Quality and compliance related services in pharma and medical device production, incl. preparation, review and handling of SOP’s, batch release documentation, change requests, deviations and CAPA’s
Quality Management System preparation and implementation
Audits, Gap Analyses and Inspection Readiness services
Pharma & Biotech Engineering
Aptio Group provides highly qualified services within all the relevant technical disciplines involved in establishment and revamp of manufacturing facilities in the pharma & biotech industry.
We provide engineers within a wide range of technical disciplines through a broad professional network and partnership model.
Our disciplines include Active Products, Fill/Finish, Assembly & Pack, Mechanical, Automation, Electrical/Instrumentation, HVAC/Cleanroom, Engineering Management, Project Management, Procurement and Project Planning
The engineering services cover all project phases from concept brief, through basic design, detailed design, construction and test to process qualification.
Our engineers are highly specialized in pharma & biotech and offer strong state of the art insight in the industry given the very broad portfolio of customers and projects they have been involved in.
We take pride in working tenaciously to solve the problems for our customers, regardless of the size or level of complexity.
Our Medical Device services are based on highly qualified consultants with +15 years of experience from many innovative Medical Device projects.
Our services within Medical Device bridge all phases from product development through manufacturing development (e.g. pilot equipment) to validated production.
Design control is the backbone of our services, and we fully understand the importance of a structured and compliant development model.
Selected services: Product development, 3D part design, Tolerance chain calculation, Creative sessions and innovation, Design for manufacturing, Design control, Product risk management, HFE – Human factor engineering, UE – Usability engineering, Design verification and reviews, Specification and test of equipment (pilot and full scale), Validation and Documentation (plans, protocols, test plans and reports)
In-depth knowledge of regulatory requirements such as MDD/MDR, FDA 21 CFR part 820, ISO 13485, Usability Engineering EN 62366, UDI (unique device identification) and normal CE marking.
We handle Medical Devices as well as Combination Products. We work both in CAPEX projects with development of new devices and with OPEX projects optimizing existing devices and related production.
An agile and innovative consultancy based on a simple business model…