Our team of auditors is composed of qualified people with many years of (senior) experience who are able to organise visits according to the client’s needs and travel independently, including using local auditors if such a particular need arises or perform audits remotely if necessary. ILC therefore carries out:
ILC supports companies/laboratories to obtain GMP production authorisation in accordance with the requirements of Italian Legislative Decree 219/2006. Our company can assist you with all aspects concerning the preparation of the authorisation application. In short:
ILC supports its clients in maintaining GMP compliance, for example:
ILC supports companies/laboratories in the execution of Self and Mock Inspections for possible inspection visits by regulatory bodies or agencies.
Staff training for all aspects of GMP application in the production chain
Training session can be arrange “on site” or via Webinars
ILC can assist the clients for the preparation of the following documentation for the APIs:
Support of activities in the field of drugs containing narcotic and psychotropic substances by our senior specialist staff.
ILC can support companies/laboratories to obtain the QMS (Quality Management System) according to ISO 9001-2015. Our company can assist you with all aspects concerning the certification path through:
ILC supports all Economic Operators in the implementation of the QMS (Quality Management System) according to ISO 13485-2016 in accordance with MDR (EU) 2017/745 – IVDR (EU) 2017/746.
Through close cooperation with the sister company Chemsafe, ILC offers the following specific regulatory toxicology activities:
All Expert reports issued are signed by our ERT® (European Registered Toxicologists).
In collaboration with specialised CROs ILC offers the setting up and monitoring (Study Monitoring) of pre-clinical and clinical studies (bioequivalence)
Pharmaceuticals have become chemicals of emerging concern due to their potential to persist into the environment and to reach drinking water leading to an indirect human exposure. Looking at the overall incidence of pharmaceuticals in the aquatic environment, patient use of medicines (prescription and over the counter) is the principal pathway. Typically, a fraction (itself or metabolites) of the medicines taken by patients is excreted and enters environmental waterways. To a lesser extent, pharmaceuticals can enter the environment through improper disposal of medicines and from manufacturing discharges. Pharmaceutical companies are therefore acting to understand such a problem for their active substances.
ILC is can offer support with the following activities
All topics/themes mentioned above can be the subject of online seminars (Webinars) held by our experts. Depending on the type of topic to be covered, our webinars last 1-3 hours. If you are interested in this training method please contact ILC at the following e-mail address: