About Us

  • 20+ years of experience in global pharmaceutical  industry
  • Proven track record in Production, Quality, Analytics
  • 10+ years technical R&D Experience
  • Leading global technical teams in international R&D  co-operations
  • Driving organizational changes, innovation and  transformation
  • Implementation of Operational Excellence
  • Drive Innovation and transformation
  • Experience in different cultural environments
  • German, English, Spanish speaking
  • Skilled and trained staff to support your requests

We are Innovation

  • Patents on new medical entities, Polymorphism and technical improvements of machines
  • First in Latin America to implement the innovative Raman technology into routine QC testing. First team ever where the Chilean health authority accepted to collaborate in a project like this.
  • Contributing in the construction and technology transfer of Latin Americas most modern plant for hormones (OEL4/5)
  • Technical implementation of an innovative 14-Carbon microdose clinical study (mass balance) – development and manufacturing of a sterile carbon 14 labelled iv-formulation
  • Technology transfer – multiple global and site transfers on commercial products and in clinical development phase II and III (API and DP)

Good Manufacturing Practice

  • Extensive hands on and leadership experience in several operational GMP areas (CMC, analytics, validation/qualification, production, development&troubleshooting) in cross cultural environments.
  • Driving Quality and Culture transformation in our Chile plant setting up systems like deviations, CAPA system, Change Control, OOS/OOT/OOE, Implementing the global Qualification/Validation strategy
  • Implementing best practice
  • Coaching the people in quality topics
  • Auditing local CMOs and suppliers
  • Coaching and preparing a site in Ecuador for an EMEA approval
  • Aligning/harmonize all our QC and development laboratories on standard operation procedures

20

Years of experience in Global pharmaceutical environment

Customers

within the global TOp 20 in pharmaceutical industry

Life Sciences and Services for R&D and Operations

We offer a broad portfolio of consulting and services to support your teams. Please let us know how we can support!

  • on the strategic level, challenging the strategy, jointly finding new ways and solutions to your projects.
  • on an operational level with management experience in the line, on project level – or in a transformation/change process.
  • ad interim until you found your ideal permanent candidate for your position.

Technical Project Management

We have experience in Technical project management in R&D and Commercial production including:

  • Early development/GLP
  • Manufacturing for clinical trial supplies
  • IND/IMPD preparation, CMC
  • Preparation for submission/Launch
  • Managing the interface between R&D and commercial production
  • Technical transfer management between sites and to/from CMOs

Quality/GMP

  • Need someone to audit your CMO’s/suppliers?
  • Unsure how much quality or GMP is required in early development?
  • Need an idea on how or up to what extend you need to qualify your suppliers?
  • Looking for a high level, however still pragmatic quality system?
  • Need upfront consulting for authority or customer audits?
  • How to implement new regulations?
  • Need support with data integrity management?
  • Bring your site up or back to GMP compliance?
  • Implement a cultural change towards quality culture?
  • Set up systems for deviations/CAPA/Change?

With the view from both the Quality assurance and Operational angle we will support you to get the best solution for your business.

Interim Management

  • We can support with qualified staff for different leading positions within Pharmaceutical/Life Sciences Technical areas in Operations, Quality and R&D.
  • Our team comprises leaders experienced in managing teams of up to several hundred FTE

CMC Consulting

IMPD / IND preparation may become quite complex when it comes to closing the gap between available R&D data and fulfilling regulatory requirements for clinical trials. 

International Technical Consulting & Services

Interested to start or foster business in Latin America? Looking for attractive high quality CMOs abroad? You need project managers in the region? Want to get some cross cultural insights? Our network will help and support you in whatever challenge you are facing.  

Contact

It is our mission to support your business in a sustainable way

  • Office: +49 (0) 2429 901 900
    Mobile: +49 (0) 163 142 2235
    Fax: +49 (0) 2429 901 901
  • Mail to: andreas.fischer@aixilia.com
  • Dr. Andreas Fischer
    Aixilia Consulting & Services
    Stockberg 16
    D-52393 Hürtgenwald