PharmaLogika: the premier consulting firm for pharmaceutical, biotechnology, and medical device companies across the globe

Through our website, involvement with sponsored events, and personal references, we reach millions every day in print, in person, and online. Our mission is to provide the highest level of expertise to both established industry leaders and startup companies from the ground up.

Our portfolio includes off-the-shelf products, management consulting services, quality systems implementation, and the skill sets required for successful discovery, through clinical trials and commercialization. We are always interested in engaging with experienced consultants in life sciences who may have specialized skills or ideas they would like to develop.

If you are interested in utilizing our services, or feel that you have a contribution to make, feel free to give us a shout!

Compliance Remediation and Quality Systems Implementation

PharmaLogika consults with pharmaceutical, biotech, and medical device quality units to provide third party audits, pre approval inspections (PAIs), compliance remediation, and a portfolio of related quality and regulatory affairs products and services. Regulatory action guidance as well as quality systems guidance are delivered as part of our standard products and services. Through the use of highly skilled resources throughout the process, each offering is designed to enact a comprehensive quality systems approach in addressing Quality Assurance (QA) issues. The results insure a close adherence to current Good Manufacturing Practice (cGMP) standards.

Remediation services are offered in response to communications (Form 483 observations, warning letters, and consent decrees) received from the United States Food and Drug Administration (FDA). Any legal action followed by an FDA inspection can be the result of a safety, quality, identity, potency, or purity (SQuIPP) deficiency for pharmaceuticals (21 CFR 210 - 211) and biologics (21 CFR 600). We conduct compliance upgrades for manufacturing, packing, storage, or installation process nonconformity with CGMP requirements of the Quality System (QS) regulations for medical devices found within Title 21 of the U.S. Code of Federal Regulations (21 CFR 820). We assist companies in reestablishing their regulatory compliance for adulterated products that are intended to affect the structure or function of the body, medical devices, or foods and dietary or nutritional supplements.