Portalis Limited and IN2trace are pleased to announce their technical and commercial alliance, in the pharmaceutical packaging serialisation sector.
Bringing a proven holistic method of turnkey serialisation solutions to advise, design, build, install and maintain your company’s compliance requirements.
The EU Falsified Medicines Directive 62, the deadline for serialisation completion has been confirmed as February 2019. Time is ticking, contact us now to get serialised.
The unique alliance of Portalis Limited and IN2trace and their respective areas of expertise and experience, ensures a symbiotic solution from genesis to delivery.
The fact is that serialisation will bring major changes to the production processes of pharmaceutical products and several other industries supply chain. The majority of the largest worldwide markets already defined deadlines for full item based serialisation of pharmaceutical products.
So far, from 2016 to 2023 all prescription drugs (and some OTC’s) on markets such as the European Union, United States, Brazil, Argentina, Turkey, Saudi Arabia, China, India and South Korea will have to be serialised. The majority of other countries are either announcing or considering legislative changes to implement serialisation also.
Initial consultation workshop to define the client scope. Assist in the development of the URS – user requirements specification to futureproof the client solution using proven and evolving technologies and methods.
Design, project manage, build, install and maintain under a SLA – service level agreement, with a holistic turnkey approach across all levels 1-4 of the ISA 95 model. We uniquely offer the capability of national system repositories, while utilising fixed or mobile software solutions for pharmacy point of sale verification.
Delivered by the proven Portalis Limited methodology of SPE © – Special Purpose Engineers, a team deployment, who bring their technical expertise and training to the project, along with project governance provided by Portalis SPM – Senior Program Managers for global projects and TPM – Technical Project Managers for regional and site specific deployment provides a high level of confidence to guarantee the service level solution delivery.
Our alliance will continually monitor the market for changes to national and international requirements and apply adaptive solutions by incorporating evolving technology. An example of this is the use of RFID – Radio Frequency Identifiers and NFC – Near Field Communication device technology as data carriers in the supply chain.