Cosmotrace is a leading Life Sciences Consulting organization that offers customized support and premium services on product serialization. Their team of experienced Serialization consultants helps Life Science companies manage Serialization & Traceability projects seamlessly.
They provide end-to-end serialization services like new partner on-boarding, project management, validation package, alert management, master data governance to name a few which are tailored to the needs of their unique clients.
Why choose CosmoTrace as your Serialization implementation partner?
They have a number of years of experience managing Serialization projects with a host of reputable Pharma companies. Their main focus is on delivering the absolute best Serialization support by offering long-term serialization strategies and forward-thinking Industry solutions. The team at CosmoTrace includes technical consultants, system validation experts and project managers with serialization experience.
As your serialization partner, Cosmotrace will do the heavy lifting taking care of all the challenges that you could possibly face with implementing and managing Serialization projects while you focus on your core business.
Effective project management is crucial to keep the project framework in place. Pharmaceutical companies need to build a robust system for Serialization Project. Management not only to manage the activities of different L1-L5 partners involved but also to ensure that the internal workstreams like labeling, validation, change management, IT infrastructure, plant sites, and others are managed and the risks associated with them are constantly reviewed, discussed, and mitigated.
They at Cosmotrace have seasoned project managers with expertise in handling end-to-end serialization projects and keeping them on track to make sure your projects are within timelines. They work on stimulating productivity, managing & monitoring schedules, budget and resources, handling stakeholders’ expectations, improving project transparency, and providing vision to the team at different stages of the project which plays a critical part in the success of any project.
The key factors to consider when validating the system include the schedule to create routine documented evidence for audit purposes, using risk-based approaches to keep validation costs in check and within budget and keeping the tasks shared within internal and external resources to properly and effectively manage system validation.
The experts at Cosmotrace provide you with validation documentation that is both detailed and audit ready.
Onboarding new business partners can be challenging as each onboarding is unique in its own way because of different requirements, different system providers (L1-L4), country compliances and file formats required for the message exchange. Cosmotrace helps customers in seamless onboarding of partners with their expertise in understanding and working with various level 4 systems like TraceLink, Tracekey, Arvato, SAP ATTP/ICH, Rfxcel to name a few.
Pharmaceutical industry is heavily regulated and competitive. In order to maintain an edge on their competitors, the pharmaceutical companies need all of their processes to be managed effectively and efficiently which is not always achievable because of shortage of skilled workers, time & budget constraints.
Cosmotrace provides managed services to help those companies by managing their serialization operational activities, providing country compliance support to prepare them for the existing and upcoming regulatory requirements, performing system health checks and if needed taking care of the end-to-end project management activities which help them focus on their other day to day processes.
Dynamic Regulatory Changes
Regulations in the pharmaceutical industry are complicated and forever changing as the focus of the regulatory bodies in each country is to make sure that the drugs being administered in their countries are of the highest standards in terms of safety and quality. This means that any pharmaceutical company looking to export medicines to other countries or to even distribute them locally needs to follow a stringent set of measures to comply with the regulations.
The team at Cosmotrace keeps a watch on the changing landscape in regulatory requirements and we regularly publish important updates for all geographies which can be viewed at their blog.
Outsourced Serialization management
Building a serialization practice in house takes time and effort and though having in house resources is desirable, the process becomes too dependent on key people and serialization is a task that has the potential to quickly become overwhelming. Having a Serialization Implementation Partner brings drop in expertise to handle the complexity and unpredictability of Serialization management as well as keeping in check the regulations of the target Markets.
Cosmotrace has a team of experts which include technical consultants, system validation experts and project managers which provide an end to end ecosystem and time tested approach and are trusted by top pharma companies in Europe to efficiently and cost effectively manage their serialization projects.
About Pharma Supply Chain and Logistics Innovation Programme 2022
Pharma Supply Chain and Logistics Innovation programme is a promising conference of World BI, focusing on different aspects of supply chain challenges especially during the COVID-19 pandemic. Get to know how supply chain professionals ensure the agility and visibility of the complex supply chains with the technological advancements in the world nowadays. Implement the robust supply chain plans as forecasted and monitoring the distribution network, keeping in mind the last mile delivery and patient centricity.
7th Pharma Supply Chain and Logistics Innovation Programme to be held in Basel, Switzerland on 10-11 May 2022.
8th Pharma Supply Chain and Logistics innovation Programme to be held in Munich, Germany on 23-24 November 2022.
This year Pharma Supply Chain and Logistics Innovation programme will come up with new flavors discussing all the challenges for a disrupted supply chain post covid, supply chain management and supply chain differentiation covering technological advancements. This conference is a blend of discussions featuring end-end supply chain, supply chain optimization, product security & authentication and regulatory compliance.
Speakers & delegates such as MSD, GSK, Novo Nordisk, Vifor Pharma, Bayer, Johnson and Johnson, Novartis, Cytvia, Clover Biopharma and many more are looking forward to joining this conference.