Regulatory Services

As a leader in the pharmaceutical Egg Lysozyme, Egg Proteins and Pancreatic Enzymes market, our company has extensive experience, knowledge and a long-standing track record in successfully submitting Active Substance Master Files [ASMFs] for Active Pharmaceutical Ingredients [APIs] to the major authorities worldwide. Full Chemistry Manufacturing and Control [CMC] service is provided to our partners in order to support them with the supply of registration/validation material and commercial manufacturing. Our regulatory department further provides all required documentation for a successful registration.

Beside the pharmaceutical sector our company also has experience and knowledge in successfully submitting dossiers for the approval of egg lysozyme use within different foods to the major authorities worldwide (EC, FDA, Health Canada) and it is active in the preparation of application dossiers for enzymes extracted from porcine pancreatic glands.

Bioseutica’s Regulatory department also provides technical documentation to support our commercial partners’ registration applications in the animal health and feed sectors.

  • Bioseutica regulatory 
  • Division
  •   PHARMA      
  •  FOOD          
  •  TECHNICAL    
  • HEALTH & FEED
Bioseutica Lysozyme-derived OK OK OK  
Bioseutica Pancreatic Enzymes OK OK    
Bioseutica Egg Proteins OK   OK OK

Bioseutica Regulatory 

For additional details about Bioseutica's regulatory services please contact: regulatory@bioseutica.com