"There is a zero-error culture in the industry, and we guarantee that"

We help you achieve compliance within:

Biopharma and Biotech

Within Bioharma, we offer experienced consultants and specialists for the preparation of and support for:

  • Quality project plan
  • Protocols and test plans
  • Risk assessment
  • Requirements specifications
  • Gap analyzes and inspections
  • Qualification (IQ/OQ/PQ)
  • Validation (cleaning, sterilization, processes)
  • User manual (SOP) and training

Pharma

Within Pharma, we offer consultants and specialists for the preparation of and support for:

  • Quality project plan
  • Protocols and test plans
  • Risk assessment
  • Requirements specifications
  • Gap analyzes and inspections
  • Qualification (IQ/OQ/PQ)
  • Validation (cleaning, sterilization, processes)
  • User manual (SOP) and training

Medical Device

Within medical devices, we offer consultants and specialists for:

  • Design control – review and approval
  • Risk management
  • Gap analysis
  • Test method validation
  • Test protocol, test references and test plans (R&D, process, sterilization)
  • Regulatory Assistance (eg MDR 2017/745, MDD)
  • Construction and implementation of a system for quality assurance, QMS (e.g. ISO13485:2016)

Environmental monitoring

Within environmental monitoring, we offer consultants and specialists for:

  • Trend reporting and reporting
  • Qualification of clean room:
  • Design URS
  • Risk assessments
  • Preparation of SOPs
  • Protocols/reports (IQ, OQ, PQ)
  • Routine monitoring
  • Education and training

Who are we?

A little over 20 years ago, AL Engineering was founded by John Albertsen, who previously had a background as responsible for the development and manufacture of equipment for the pharmaceutical industry. Actually, AL Engineering was supposed to take on small tasks that John could carry out himself, but the customers quickly came back with more tasks, and today the company is 20 years old and houses more than 15 consultants.

Our mission has never been to be the biggest consultancy – but rather to be the best consultancy for our customers. In fact, John focused so much on the quality of the service that he forgot to attach great value to the name of the company – and therefore it was his initials AL that added to the name.

Do you want to read more about how AL Engineering started? Read the anniversary interview about John Albertsen in connection with the celebration of AL Engineering’s 20th anniversary.

Where do we live?

We currently live in Holbæk in West Zealand, where we have lived at Hørbygaard Gods for the past 8 years. Here we are often visited by happy deer, curious squirrels and beautiful pheasants – so even though we live a bit out in the country, we never feel completely alone!

Do not hesitate to contact us

Tuse Næs Vej 7C, 4300 Holbæk
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