About KCS

Kucera Consulting Services, LLC (KCS) was founded with the goal of providing expert consulting support for the pharmaceutical industry and academia. Our consulting company specializes in providing support to pharmaceutical companies, Quality Control departments, Analytical Development and R&D Laboratories, to assure that procedures adhere to current FDA, USP and ICH guidelines. We provide assistance with remediating FDA Consent Decree issues, addressing FD 483 form analytical issues and documents for FDA in support of pharmaceutical products. We review raw analytical data, review and help with laboratory investigations (CAPA), and issues with Over-the-Counter nutritional and botanical products.

KCS is involved in auditing pharmaceutical laboratories, preparation of Standard Operating Procedures, qualification of analytical equipment, preparing analytical protocols and reviewing analytical documents to support marketed products, We review and provide advice on method development, method validation and method transfer, cleaning validation methods, stability studies, review clinical drug studies with humans and animals, chemical and physical qualification of raw materials, qualification of reference standards and establishing developing strategies that will provide the most efficient and direct path towards registration of analytical documents.

We also provide training on major FDA, USP, ICH guidelines and analytical instrumental techniques (chromatography, spectroscopy, UV/IR, NMR, MS), required in support of regulatory submissions for ethical drug substances, drug products, and OTC and botanical products. We prepare forensic procedures and provide advice in situations involving drug tampering, counterfeiting, analysis of toxic substances and drugs of abuse and elucidation of drug degradation pathways.

KCS possesses a vast array of pharmaceutical analytical chemistry, organic chemistry, chemical kinetics and regulatory expertise, a thorough knowledge of the regulated drug industry and the drug development process and, if needed, can access an extensive network of other independent providers of specialized drug development services.