Digitalisation in the Pharmaceutical Industry
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Confidence Beyond Compliance
Today‘s ever-changing market requires expertise and innovative solutions to overcome the challenges of tomorrow. PharmaLex provides regulatory affairs solutions, combines global reach with local presence for its Global End-to-End Full Outsourcing solutions. PharmaLex has an outstanding successful track record and many years of experiences, to provide a viable End-to-End solution, capable of maintaining your products throughout the life cycle while ensuring the highest quality and compliance globally and locally.
The regulatory maintenance of approved products is essential and critically important for pharma compliance. PharmaLex is able to support Pharma companies to refocus their workload on core strategic competencies, and alleviate the challenges caused by constant demands for pre- and post-approval activities for complete product portfolios. At PharmaLex we live what we preach by taking over full responsibility of your product portfolio either globally or on a country level giving you confidence that your products are in good hands – beyond compliance.
PharmaLex has a long history of managing End-to-End full pharma outsourcing programs encompassing the areas of RX, OTC, food, cosmetic and veterinary products.
With our attractive near-shoring models we are able to offer competitive prices while ensuring high quality and instant support in the same time zone as our clients.
The following services are offered in course of our End-to-End full outsourcing programs:
- Provision of full portfolio outsourcing from global / head-quarter to local affiliate activities including responsibilities in the area of global labeling, CMC (change control and writing), market expansion, worldwide renewals, line extensions and publishing
- County-based outsourcing taking complete responsibility of all maintenance activities on a local level (Regulatory and Pharmacovigilance activities)
- Establishment of clear program governance structures
- Controlling and performance measurement via budget & KPIs
- Guiding process consultancy and operative innovations
- Supporting large globally acting customers with small or large number of established products
- Handling of activities within PharmaLex own systems
- Provision of full portfolio responsibilities including global labeling
- Establishment of clear program governance structures
- Controlling and performance measurement via budget & KPIs
- Guiding process consultancy and operative innovations
- Supporting large globally acting customers with small or large number of
established products
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What our clients say
Provided honest feedback and collaborative working solutions to obstacles
South Korea based medium sized company
Manager
Manager
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.
Lorraine Henry
Compliance Lead, Qualified Person, Amneal Ireland Limited
Compliance Lead, Qualified Person, Amneal Ireland Limited
