Contract Development of Finished Drug Products

Midas offers „one stop shop“ solutions with comprehensive management of all project phases. We assess the feasibility of the product candidate and manage the development, IP protection, registration as well as the supply of the finished product ready for marketing.

Upon your request, our modular services could start already at ideation level

Midas is able to support already in the ideation phase. E.g. within the scope of a joint brainstorming session, Midas helps to shape the first - even if not yet very concrete - ideas to generate options for potential candidates. Following an initial appraisal of such candidates, Midas supports your selection the most promising options. Thereafter, these product option will be transformed by Midas into a respective definition of clear first target product profiles.

Contract Development of finished drug products
*Product Life Cycle Management ideas or attractive portfolio extensions, developed jointly with customer

Learn more about the individual project phases: 

  • Step 1: Idea Phase

    Feasibility Assessment:

    Midas evaluates whether the intended product can be realized from a technical, regulatory and commercial point of view:

    • Commercial analysis (competitiveness, API sourcing, ...)
    • Check of regulatory requirements
    • Evaluation of technical hurdles
    • First estimation of development costs & time

    IP Analysis

    • “Freedom to operate“ patent report
    • First evaluation of potential for relevant own IP claims
  • Step 2: Development Phase
    • Midas is not bound by the limitations in technical eligibility or scale of own equipment. Midas’ experts select the most suitable CDMO as per individual project requirements (technical and commercial eligibility as well as reliability).
    • Assessment of costs and time required to realize the product opportunity: Midas will provide a detailed quotation, which will make all necessary project steps easy to understand and to follow-up.
    • Qualification of development & manufacturing sites
    • Audits of GMP relevant sites (API and FDF)
    • Securing customer interests by taking care of negotiating all relevant contracts
    • Comprehensive project management: from definition and systematic testing of critical parameters (quality by design) to guiding and monitoring all development work
    • Regular review of all data/documents intended for registration (regulatory compliance check)
    • Constant IP monitoring, assessment and filing of potential own IP claims
  • Step 3: Registration Phase
    • Advising on choice of procedure and related authority
    • Preparing and arranging pre-submission/scientific advice meetings with regulatory agencies on behalf of customer
    • Dossier preparation and submission
    • Acting as applicant, taking care of required administrative steps and authority demands (incl. Pharmacovigilance)
  • Step 4: Commercialization
    • Manufacturing & Supply
    • Ensuring timely availability of API and all materials needed for production in batch sizes according to marketing requirements
    • Primary packaging solutions potentially enabling superior stability
    • Order management & Launch preparation
    • Reliable supplies: ensuring that ordered products will be available in time as well as in the right quality and quantity

Your Contact

Dr.  Tanja Westphal-Mirzad

Dr. Tanja Westphal-Mirzad

Finished Products Development
Director

Midas Pharma GmbH
Rheinstr. 49
55218 Ingelheim
Germany

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