Our Services

Why advice from us?

There are companies operating in the market of different sizes and skills. Amongst them there is a certain group that offers consultancy across the whole sector, but there are also some focussing on special issues. Our focus is essentially built and based on the experience and knowledge made and gained. We are proud of our scientific and technology record of innovations implemented. Founded on this fundamental basis, we are assisting our clients to chose the most appropriate risk assessment and risk management tools to manage their diverse processes and procedures. In doing so, we cover areas including but not limited to:

  • Development
  • Validation/ Qualification
  • Manufacturing
  • Quality Control
  • Quality Assurance
  • Compliance
  • Meeting FDA expectations

In particular, we offer services in the field of pharmaceutical manufacturing and control for:

  • active pharmaceutical ingredients and drug substances
  • sterile medicinal products
  • medicines of high potency (cytotoxic, cytostatic, etc.)
  • documentation and preparation of inspections by the Competent Authorities
  • adaptation to the regulatory requirements
  • training
  • Audit

Services provided in these areas, are our speciality. If you want to know more about it click here.

Detailed list of services offered

As mentioned above, the consulting services offered are focused on the field of sterile medicinal products. To summarise the types and topics of consultancy we offer concerning sterile medicinal products, the following list might be of help:

  • advice in the development of manufacturing products using aseptic and/ or terminal sterilization processes
    • including lyophilisation and freeze-drying processes
    • technical and scientific advice to the above

  • support in planning and implementation of process up-dates and improvements

In particular, in the field of high-potent drugs we offer:

  • consulting in health, environmental protection and safety
  • use of innovative technology
  • tools and processes to protect operators
  • support in planning and implementation of process up-dates and improvements

In the area of quality control, we offer:

  • organisational and operational advice for the laboratory
  • technical and scientific advice
  • consulting in the field of collecting, storing, tracking and data evaluation
  • consulting in development and validation of analytical methods
  • support in planning and implementation of processes and updated methods

In particular, in the area of documentation and preparation for inspections by the Competent Authorities we offer:

  • audit and inspections such as "mock" exercises
  • review of existing documents
  • support for the creation and issuing of critical documents missing
  • checking the consistency of existing documents and processes with the dossier and documentation provided to and filed with the Competent Authorities
  • support in planning and implementation of process up-dates and improvements

In order to achieve compliance with the regulatory requirements, we offer:

  • verification of process and documentation for consistency with pertinent international norms
  • support in planning and implementation of process up-dates and improvements

With regards to training, we offer:

  • courses on basic manufacturing processes and unit operations for sterile medicinal products
  • courses on the basics of fundamental processes involving high-potency drugs
  • courses on data management and execution of analytical methods in quality control
  • refresher courses on recent developments of the pertinent rules, norms and regulations
  • support in planning and implementation of training in particular on processes, procedures, methods and behaviours necessary in sterile environments

If these competences are sought by you, please don't hesitate to contact us! Ask for a preliminary and non-binding offer. Contact us!