We will support you in developing and registering your medicinal product(s), such as small molecules, biologics, biotechnology derived products, and vaccines. We do this efficiently with respect to time and costs. The four pillars of our approach are to keep the helicopter view, to look for potential opportunities, communicate any risks and to find the optimal solution for issues at hand. In addition to quick market access and low costs, this enables you to maintain good relationships with health authorities worldwide.

When you tell us about your goals, we focus on meeting them. We start with thinking about the appropriate regulatory framework and  types of applications that might apply. Examples of types of applications we advise on, prepare and submit are:

  • Applications for clinical trials in adult and pediatric populations
  • DMF, ASMF and CEP applications for active pharmaceutical ingredients
  • New applications for small molecule products, generic, hybrid, and well-established use applications
  • New and biosimilar applications for biologicals, biotechnology derived products and vaccines
  • Applications to obtain an orphan drug designation for products which treat rare diseases
  • Post-approval applications such as variations, amendments, renewals, annual reports but also mutual recognition, repeat use procedures

In addition to our capability to interact with the European Medicines Agency (EMA) and Federal Drug Administration (FDA), we are able to support you with preparation and submission of comparable applications worldwide.  The names of applications mentioned above are mostly based on the names used in guidelines by the European Medicines Agency (EMA) and Federal Drug Administration (FDA). 

When assessing the available information on your product, we start looking for potential opportunities, risks and solutions to issues. We are able to:

  • Provide you with SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis for your product(s)
  • Give you insight in the potential for successful registration of your product(s)
  • Define the optimal regulatory strategy during development and post-approval stages of the product life cycle
  • Prepare scientific advise meetings with health authorities and represent your company during the actual meeting
  • Prepare study plans, as well as author protocols and reports
  • Author CTD sections
  • Prepare and collect ancillary documents
  • Prepare responses to questions from health authorities
  • Perform all post-approval dossier maintenance and life cycle management activities
  • Perform compliance checks; check if your dossier is in line with the actual practice

We are knowledgeable in:

  1. General
    • Development of active pharmaceutical ingredients, medicinal products and reformulations
    • Different dosage forms, e.g. oral, parenteral, topical, ophthalmic, inhalation and suppository dosage forms
    • Summary of product characteristics, package leaflets, labelling and mock-ups
  2. Quality
    • Pharmaceutical development
    • Manufacturing processes (septic and aseptic), sterilization processes and validation of these processes
    • Specifications, analytical methods and validation of analytical methods,
    • Container closure systems
    • Stability studies
    • TSE/ BSE and viral safety
    • Requirements for relocation of manufacturing processes, packaging activities, analytical testing and batch release activities of active pharmaceutical ingredients, excipients and medicinal products
  3. Preclinical
    • Safety pharmacology studies
    • Pharmacokinetic studies; absorption, distribution, metabolism and excretion studies as well as drug interaction studies
    • Toxicology studies; single and repeat dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and local tolerance studies
  4. Clinical
    • Bioavailability and bioequivalence studies
    • Pharmacokinetics studies (in vitro and patient studies)
    • Pharmacodynamics studies
    • Efficacy and safety studies