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develco-header-entwicklung

Implementation of the productdefinition
to new maketable products

develco-entwicklung

Development & Licensing

Development describes the process from translating the product definition via technical and clinical studies to an approvable and marketable product.

This process includes:

  • The technical experiments search for a suitable formulation (mixture of active pharmaceutical ingredients and excipients)
  • The development and validation of suitable analytical methods for quality control
  • The real-time stability testing of the formulation in the designated primary packaging
  • The proof of the ability to produce on a commercial scale
  • The investigation of preclinical data on adverse effects (toxicity) in animals and distribution in the body (pharmacokinetics or bioequivalence) of healthy subjects
  • The collection of clinical data on effectiveness in patients

Contacts:

Dr. Hélène Rey
Director Research & Development

Dr. Nils Burger
Head of Clinical Development

Innovation & Produktdefinition

The development process ends with the submission to the competent authorities for marketing approval. After approximately one year of evaluation by the authorities, which confirms that the development and the collected data complies with regulations, permission is granted to distribute the drug commercially, which allows doctors to prescribe the new medication for the treatment of patients.

Develco Pharma has an extensive and remarkable expertise in the development of medicinal products. This expertise does include innovative and creative approaches to difficult problems. This advantage in knowledge results in development and approval of new products within a shortened timeframe.

In-house, the focus lies in the technical development comprising of formulation and analytical development as well as production scale-up. Preclinical and clinical development, as well as in the regulatory approval process, Develco Pharma can look back on a long and successful cooperation with designated experts and specialized companies. However, Develco Pharma is capable to control the entire development process with its own employees and infrastructure.