Is your proprietary or generic product ready for the Manufacturing and Industrialization phase? Congratulations!
Is your proprietary or generic product ready for the Manufacturing and Industrialization phase? Your journey to achieving a great new drug to the market is near to the finish sign. At this stage of product development, the amount of work in your laboratories probably grows exponentially and a way to stay in control of all the processes is to purchase services to meet the deadlines. We will help if you need to perform physical analytics.
A list of questions that might help you define the project:
- Are you searching for aid for method development and validation for Quality Control?
- Do you know your critical material attributes?
- Do you need to clarify the root cause of your manufacturing troubles?
- Is your manufacturing process sensitive to the batch-to-batch variations of raw materials?
- Is the particle size or the solid-state form of your drug substance affected by your manufacturing process?
- Do you need our help in the characterisation of intermediates: granules, tabletting mass, tablet cores?
- Are you scaling up the drug substance synthesis and crystallization, changing the manufacturing site, or searching for the new drug substance or excipient suppliers?
- Do you need to have marketing authorization for your new product?
- Can you prove your product’s physical stability or justify the drug product specifications to authorities?
- Do you need assistance to formulate your answers to drug authorities questions related to drug substance particle size and polymorphism in your drug product?
Use or potential to perform physical analytical work and consultancy for you.
Outsource the most routine and laborious quality control and GMP stability work to us.
Particle Analytical is approved as a GMP laboratory by the Danish Medicines Agency (DMKA) and registered with the FDA. The approval by DMKA applies to both human and veterinary medicinal products.
Use the contact form to request the certificates.