Confidence Beyond Compliance

During the drug development process, the batch sizes manufactured generally increase. The early stage clinical trials usually involve using a small dosing regime to a small number of subjects, saving the majority of the manufactured product for stability studies and analytical testing. As the development process progresses from formulation design to Phase I clinical trials and subsequently through to Phase II & III, batch sizes continue to increase. If the clinical trial outcome is positive, resulting in the granting of a marketing authorization, the batch sizes manufactured may continue to increase further to cover the market demands.

Value Added Medicines developments aim at enhancing well-established, off-patent molecules by optimizing their efficacy, tolerance, or ease of use or even exploring them in new indications. Despite the obvious benefits these products offer to the patient, the lack of adequate incentives, pricing and reimbursement call for time- and cost optimized development and regulatory strategies.

PharmaLex can leverage decades of international drug development & registration experience, as well as support clients to coordinate and communicate drug scale up with relevant authorities to stay compliant. We have successfully managed development efforts from the lead compound / idea through to market approval and lifecycle management worldwide. Let our experts design a strategic solution that is tailored to your development goals.

Development Strategy and Gap Analysis

  • Creation of development plans and target product profiles
  • Managing health authority interactions (meetings, written advice)

CMC, Non-clinical and Clinical Development Consultancy

  • Study design & protocol development incl. biostatistics & data management
  • Regulatory writing (e.g. eCTD Module 2 documents, ISS / ISE)

Quality Program Development and Review

  • Developing fit-to-purpose QA and QC programs
  • Due diligence evaluation of QA Systems

Submission Management

  • Marketing applications and regulatory procedure management worldwide (MAA, NDA / BLA) e.g. Clinical
    trial applications (e.g. IND / IMPD)

Leveraging special regulatory provisions to optimize development & approval time and price negotiations

  • Orphan drug designations (EU, US)
  • Pediatric development plans / waivers (PIP / PSP)
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