• Regulatory Consultancy for
    Bio-/Pharmaceutical Companies

  • Authorization of Medicinal Products

  • Interim Management
    Regulatory Affairs

  • GxP Audits

  • Dossier Compilation

  • Scientific Advice

  • Due Diligence

BioRegĀ® at a glance

BioReg is a Consultancy specialized in providing strategic advice and practical implementation of legal requirements for medicines with focus on biopharmaceuticals.

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.