FDA CONSULTING SERVICES
12 Starlit Drive
Northport, NY 11768-3514
631-754-0415 (phone and fax)
CLORENTZSON .com
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FDA Approval - FDA Regulations - FDA Compliance
Need HELP with the U.S. Food and Drug Administration?
We have the experience and knowledge that it takes to help you navigate your way through
the FDA regulations and make your business more profitable. We monitor changes
at the FDA and can serve as your watchdog, saving costly additions to your staff. We will assist
the pharmaceutical, cosmetic and health-food industries with:
- ANDA audits
- Establishment of an acceptable company GMP profile
- Developing and correlating data for:
- FDA IND submissions
- NDA and ANDA submissions
- Type I and Type II Drug Masters
- Developing in-process validation
- Preparing Standard Operating Procedures (SOP)
- Pharmaceutical formulation
- Company or product acquisition
Domestic and International Experience
Carl Lorentzson, a former FDA Group Supervisor and registered pharmacist, heads Lorentzson
Consulting Services (LCS). Carl has over 28 years of FDA experience, including plant
inspection and plant evaluation, both here and abroad. He has also brokered the sale
of a pharmaceutical firm.
LCS associates are highly qualified and widely experienced. One is a Ph.D. and co-author of
Pharmaceutical Process Validation. Another is a former executive of the FDA Generic
Review Branch. One has served as Scientific Director for a major firm and has
over 30 years experience in formulation, production, quality control and regulatory matters.
The associate who consults on dermatologicals, has a Ph.D. in Pharmacology and substantial
expertise in pharmacological and clinical testing of drugs and cosmetics.
Another, with a Ph.D. in Pharmacy, is an expert on water, sterility and bacteriological matters.
Formulation development is guided by an associate with a Ph.D. in Pharmaceutical Chemistry
with many years of industrial and academic experience.
Personal Service
We are small enough, that we can give each of our customers the personal, caring attention
that they deserve. Contact us today. How can we help you?
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