The pharmaceutical sector includes companies that contribute to the research, manufacture, and sale of drugs (or vaccines) for human or veterinary medicine. This activity is carried out by pharmaceutical laboratories and biotech companies. The use of these products is dedicated to maintaining the health of people and animals.
Challenge and solutions
Products require approval before they can be sold.
How can a company manage its marketing authorization portfolio, the lifecycle of marketing authorization documents, their digitization, updating, and submission on an “as-needed” basis?
Regulations require complete justification.
How can a company respond to regulatory requirements on an item by item basis (GMOs, allergens, REACH/RoHS)?
- Intellectual Property
A number of molecules have fallen into the public domain.
What’s the best way to address generic drugs?
There is an increasing amount of “academic spin-off” and CROs.
How can upstream (research) and downstream (clinical trials) communication among partners be clarified?
PCO INNOVATION'S SOLUTIONS
PCO Innovation will advise and accompany you in the implementation of PLM best practices:
- Document management
Can be used to manage basic document building blocks in the marketing authorization record.
- Configuration management
Basic documentation building blocks can be used to assemble marketing authorization records (a document building block can be shared by several records or a specific record).
- Portfolio management
Helps provide a comprehensive vision of products and marketing authorizations.
- Project management
Helps guide submissions to various health agencies.
VALUE ADDED BY PCO INNOVATION
- Specialized in PLM: focusing on our core business and supporting our clients’ innovation.
- We consider information technology to be a means, not an end.
- Dual competency in the business (Pharmaceuticals) and the technology.
- We propose a complete and complementary line of services, from the analysis phase to completion.
- We provide a unique level of expertise and responsiveness relating to PLM solutions in the market.
- We value a commitment-based approach.
- We combine the flexibility of a human-sized company with the ability to support large-scale PLM projects.