Most relevant regulations for biomedical sector are included (Pharmaceutical, Veterinary, Biosecurity, Cosmetic or sanitary producs) in order to accomplish the requirements in a facility, project or production process. In case of being interested in having more details of the current legislation in a sector or having doubts for the proper interpretation do not hesitate to contact us we will help you:
We can also help bring your project to the most important regulatory agencies (AEMPS, EMA, FDA, Anvisa or any regulatory agency) for review and approval or clear any doubts about the regulatory agencies before or during the project.
We ensure that projects designed and implemented by Ingelyt conform to the current regulation in order for the facilities to be approved by different regulatory agencies for higher requirements markets, being able to perform all required documentation for its approval (technical report, Site Master File (SMF), qualifications of facilities and equipment, pharmaceutical plans, risk analysis, process validation protocols, simulation aseptic protocols (Media Fill), ….)

  1. Good Manufacturing Practices (GMP)
  2. Pharmaceutical Legislation
  3. Steril product legislation
  4. Cosmetic product legislation
  5. Biosecurity

1. Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) are the basic guidelines for defining quality standards in medicines manufaction. They are mandatory for the pharmaceutical industry.

2. 2. Pharmaceutical legislation

More relevant pharmaceutical international regulation in order to meet international requirements in facilities and manufacture of medicines

Steril products legislation

Sterile products as the risk that they suppose for the final user, have a specific regulation that must be met by the different manufacturers.

The most relevant pharmaceutical international Regulations in order to meet international requirements in manufacture of sterile products.

Cosmetic products legislation

Manufacture of cosmetic products has a specific legislation for the facilities and manufacturing processes of cosmetic products.


The manipulation of living microorganisms needs a few specific requirements in the facilities destined for their manipulation shuch as investigation centers or manufacturers laboratories of biological origin medicines.