• Regulatory Consultancy for
    Bio-/Pharmaceutical Companies

  • Authorization of Medicinal Products

  • Interim Management
    Regulatory Affairs

  • GxP Audits

  • Dossier Compilation

  • Scientific Advice

  • Due Diligence

BioReg® at a glance

BioReg Consultancy operates as Management Consultancy specialised in strategic advice, interim management and hands‐on support for all aspects of development, manufacture, clinical trials and authority approval (licensing) of biopharmaceutical medicines.

BioReg Consultancy will help your company to

  • develop strategies for the fastest route to the market
  • meet your timelines by excellent communication with your people and managing your projects
  • license your products successfully by adapting diverse legal requirements to find optimal solutions for your product and needs
  • maintain your marketing authorisation after approval during life cycle management

Your benefit will be a streamlined decision and development process leading to shortened approval times. We are committed to your requirements. We step into your shoes.

Biopharmaceuticals are biological medicinal products such as

  • Extracted from biological sources:
    • Blood and plasma components like immunoglobulins, albumin or clotting factors
    • Vaccines based on inactivated bacteria (typhus) or their toxins (tetanus) or viruses (influenza)
    • Stem cell therapy
  • Manufactured in living cells by recombinant DNA technology:
    • Monoclonal antibodies
    • Other recombinant proteins, e.g. insulin, albumin, fusion proteins
    • Biosimilars
  • Allergens
  • Gene therapy products based on nucleotides:
    • Live recombinant vector vaccines
    • DNA vaccines
    • Crispr
  • Somatic cell therapy products:
    • Allogenic pancreatic islet cell for Type I diabetes
    • Denditric cells loaded with components as tumour vaccine
    • Chondrocytes for cartilage repair
    • Adoptive cell transfer (e.g. CAR-T cells)
  • Tissues engineering products:
    • Cartilage repair, skin regeneration
    • Organ engineering for lymph nodes etc.

Advanced Therapies Medicinal Products (ATMPs) comprise products from gene therapy, cell therapy and tissue engineering.