- Pharmaceutical Registration Consulting.
From 1989 to 2000 I was a pharmaceutical researcher at R&W Bio Research, a Netherlands based CRO. See also this post. During this time I was (amongst others) responsible for (veterinary) Pharmaceutical registration.
Starting with part 2 (pharmaceutical part) and later on also Pharmacokinetics and Pharmacodymics and later on also safety studies (GLP, Good Laboratory Practice). I also conducted clinical trials as well as Bioequivalence studies.
After one year in the lab as active researcher I became Study Director for analytical method development using GC, HPLC, MS, GC-MS and LC-MS.
During this period me and my team developed and validated all over 25 analytical methods for determining pharmaceutical active ingredients in body tissues, blood, urine, faeces and the environment and over 300 analytical methods to measure the concentration of active ingredients in the end-products (pharmaceutical forms).
Finally I registered about a hundred Pharmaceutical products for our customers according to international FDA requirements.
How can I help you?
We can help you with the following services:
We are specialized in concentrated multivitamins and minerals for poultry.
Poultry is the food of the future (Think of everything that can be nade of it. MacNuggets, McChicken, KFC, etc. etc.) and has an enormous potential! Think of a country like China. With almost 1.5 billion people from which maybe a few percent eat chicken products daily the potential market is huge! Billions of US dollars, just by adding 1% to this market!
Furthermore we offer:
- Pharmaceutical Product Registration (International or Philippine).
- Analytical methods.
- Laboratory Automation (LIMS).
- Implementing GLP and GMP in your company according to FDA standards.
- Quality Assurance.
- Online literature Research.
- Residue Studies.
- FDA Certification in the Philippines.
As a Consultant I’m not doing the lab work myself anymore. Research projects (except Online, which I still do myself) are outsourced to different CRO’s. This allows us to interact directly with you, the customer and advise you on marketing strategies.