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A strategic collaboration in the field of oncology

Three independent and certified European pharmaceutical companies - Bluepharma, Helm and Welding - united to form a leading partnership for complex, differentiated and high potency products.

ONConcept
Know-how, track-record and expertise

Combining their strengths, the ONConcept® alliance is providing:

  • Large basket of oncology products and other products.
  • Integrated solutions and services covering the full value chain.
  • EU-based development and manufacturing site.
  • Sound in-house scientific, regulatory and commercial expertise.
  • International networks and global experience.
  • Flexible adaptation to product- and customer-specific needs.

Know-how, track-record and expertise
Worldwide pharmaceutical corporations can now benefit from ONConcept's integrated offer.

ONConcept® is working on strategic alliances with multinationals and local companies for a basket of products. Rather than licensing one product at a time, the company will form long-term, multi-molecule alliances. ONConcept® will provide the full spectrum of its expertise and capabilities, oriented to serve the needs of its marketing partner, and work with the agility and flexibility to adjust to market or territory dynamics, for example with regard to time to market.

 

Forming the alliances will move ONConcept® toward its goal of being the partner of choice for oncology, supplied from Europe. In the coming years, the strategic alliance wants to become known as a reputable European supplier of highly potent drugs with the capabilities needed to develop, register, and supply complex products, ensuring competitiveness across the product lifecycle. In achieving that goal, ONConcept® will unlock major markets for its allies and help to expand access to life-changing medicines in Europe and beyond.

From portfolio building to product development and market supply

Pooling the complementary skills and competencies of Bluepharma, Helm and Welding, the ONConcept® covers the entire value chain - from portfolio building to product development and market supply.

Product Portfolio
Our services
Intellectual Property (IP) Support

Intellectual Property (IP) Support

  • In-depth IP analysis by highly qualified, in-house team.
  • Extensive experience in prosecution and challenge of IP.
API Sourcing

API Sourcing

  • API procurement based on over 60 years of experience.
  • Global network of established partnerships and cooperations.
FDF Development, Manufacturing and Supply Chain

FDF Development, Manufacturing and Supply Chain

  • EU-GMP approved unit, furthermore successfully inspected six times by USFDA (2009, 2012, 2014, 2016, 2019) as well as by MFDS (South Korea), MOHME Libya, SFDA (Saudi Arabia) and ANVISA (Brazil).
  • Manufacturing within site inspected by authorities, GMP-approved and located in Portugal.
  • Reliable and consistent supply from API and raw materials to commercial manufacturing.
Clinical Development

Clinical Development

  • Development of clinical programs according to international standards by in-house experts.
  • Conduct of clinical trials at European-based FDA-inspected CRO for Bioequivalence and Phase I studies.
Regulatory Support

Regulatory Support

  • Quick and smooth registration procedures according to latest EU/US requirements based on scientific and regulatory expertise.
  • Professional CMC services and performance of all tasks from development stage to registered product ready for market.
Media
Bluepharma

Our innovative nanoenzalutamide tablet development is strengthened by the recent decision of the European Patent Office

ONConcept April 2024

Our innovative nanoenzalutamide tablet development is strengthened by the recent decision of the European Patent Office to maintain Medivation/Astellas formulation patent EP3725778 B1...

Bluepharma

ONConcept® has successfully completed the pivotal BE study for Nilotinib

ONConcept January 2024

ONConcept® announces the successful completion of a positive bioequivalence (BE) study in the European Union for Nilotinib.The study marks a significant milestone in our commitment to...

Bluepharma

ONConcept® has successfully completed the pivotal BE study for Pomalidomide

ONConcept June 2023

Bluepharma, a Portuguese pharmaceutical company, has just opened a state-of-the-art industrial unit specialized in the production of oral solid high potent drugs, namely in the oncology area.

Bluepharma

Bluepharma opens an industrial unit unique in Portugal and one of the largest in Europe

ONConcept March 2023

Bluepharma, a Portuguese pharmaceutical company, has just opened a state-of-the-art industrial unit specialized in the production of oral solid high potent drugs, namely in the oncology area.

Bluepharma

How an Integrated European Hub for Complex Products is unlocking major market opportunities

Pharma Intelligence October 2022

The need for an integrated European developer and manufacturer of complex, differentiated and highly potent products is clearer than ever. Expirations on the patents and/or regulatory...

Bluepharma

ONConcept®: An Integrated European Hub for Delivering Highly Potent Complex Products

Pharma Intelligence July 2021

Off-patent, highly potent pharmaceuticals represent a major opportunity. The companies that seize the opportunity will grow sales by delivering products that improve the lives of patients...

For business inquiries
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For business inquiries contact us using the form below or send an email to business@onconceptpharma.com.

 

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Bluepharma
São Martinho do Bispo
3045-016 Coimbra • Portugal
phone.  +351 239 800 300
Helm
Nordkanalstrasse 28
20097 Hamburg • Germany
phone.  +49 40 23 75 0
web.  www.helmag.com
Welding
Esplanade 39
20354 Hamburg • Germany
phone.  +49 40 35908 - 0
web.  www.welding.eu