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PharmaLogika Consulting: Serving pharmaceutical, biotechnology, and medical device companies across the globe

Through our products, books, 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 concept through commercialization.

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. 

 

 

 

PharmaLogika offers a special resource for our community: PharmaLogika Advocate, your advocate for life sciences compliance and health care improvement.

Through our partnership with WordPress, you can find timely articles and research related to your industry and community in one convenient location. You can also reply to articles, interact with each other, and submit your professional and personal perspectives.

If you have a good piece of information, don't keep it to yourself — be an advocate and share it!

 

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  SERVICES
  bullet Quality Assurance
  bullet Regulatory Compliance
  bullet Operations Management
  bullet Clinicals Management
  bullet Product Development
  bullet Packaging and Labeling
  bullet Compliance Remediation
  arrow Corporate Governance
  bullet Consultant On Call
   
  PRODUCTS
  button Project Management Templates
  button Quality Assurance Forms
  button Training Systems
  button Books
   
  HEALTH CARE
  bullet Health Care Home
  bullet Animal Health
  bullet Consumer Care
  bullet Medical Care
   
  RESOURCES
  button Global Regulatory Links
  button Documents & Templates
  button Guidance Documents

 

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