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Florestal Consulting & Associates, Inc. - CAPA Resolution, Technology Transfer & OOS Resolution Services  Florestal Consulting & Associates, Inc. - CAPA Resolution, Technology Transfer & OOS Resolution Services

Pharmaceutical Products & Services Pharmaceutical Products & Services

 

Our Services - Consulting

With the rising trend towards stricter compliance standards, pharmaceutical companies are being challenged to comply or risk regulatory citations which can significantly impact operations. To meet these new standards in a short period requires assistance. Florestal Consulting & Associates (FCA), with over 14 years of pharmaceutical experience, is committed to providing that assistance.

Advise. Educate. Train. At FCA, we believe that strategically sound and relevant advice coupled with a strong education and training program will produce companies that are in compliance with agency standards as well as in line with its own company objectives. As such, FCA utilize these ideals to assist pharmaceutical companies in reaching their goals relating to cGMP, QA/QC, Stability, Regulatory Affairs and Technical Documentation compliance. Our goal is to be the vehicle through which our clients will not only reach, but exceed their expectations for compliance.

Our services include:

  • Validation Services
     
    • 21 CFR Part 11 Compliance
       
  • Technology Transfer
  • CMC Preparation and Review
     
  • OOS Resolution
     
  • CAPA Resolution

Technical Expertise in the following areas:

  • Analytical Techniques: GC, HPLC, FTIR, UV-Vis
  • Stability-Indicating Method
  • Development/Validation/Transfer
  • Stability Testing
    • Stress-Testing
    • Protocol Development
  • LIMS and Laboratory Data Acquisition Computer Systems
    • Part 11 Compliance
    • GAP Analysis

Who will benefit from our services?

  • Contract Research Organizations
  • Contract Manufacturing Organizations
  • Contract Testing Laboratories
  • Quality Control Laboratories
  • Regulatory Affairs
  • Documentation Department

Please visit our website at www.florestalconsulting.com and let us know how our experience can be of service to your company.

Florestal Consulting & Associates, Inc.

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Address

Florestal Consulting & Associates, Inc. Address Florestal Consulting & Associates, Inc.
  P.O. Box 463
West Orange
NJ 07052-0463
USA
Tel. +1 973 280 6675
Fax +1 973 736 1875

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