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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
What was especially important to me was their ability to get a team, with the right experience, together so quickly.
Mid-size Biotech
Head of Outsourcing
Head of Outsourcing
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
Large Pharma, Global
VP Regulatory Strategy
VP Regulatory Strategy