Our Services

NHP Compliance provides expert assistance at every stage of a GMP compliance program.

We have a team of full-time, dedicated, diversified, committed, and knowledgeable specialists; our associates are assigned to a given project to meet a client's particular needs. We are able to flex to meet changing project scopes (e.g., tightened timelines, market changes, short-term workforce shortages, etc.).

Our services include:
● Project Consulting
● Audits
● QAP Services™
● Regulatory
● Technical Writing
● Training
● Laboratory
● GMP Booklets

 

 

 

Services
 
AUDITS

Quality Assurance Report (QAR) Audits
NHP Compliance can pinpoint problems and their solutions, ensuring that your facility or operation meets GMP/ISO requirements. We will conduct a gap analysis on your Quality Systems. Then we will develop and deliver a prioritized compliance action plan based on this analysis, specifying how to prepare for your impending audit successfully. QARs are needed for any facility that manufactures, packages, or labels NHPs.

Importer Sites
Importers must submit a QAR (or equivalent – see below) for each foreign site.

 Foreign Sites
The QAR for a foreign site is valid for one year minus one day from the date of completion; it must be submitted for review with the site licence application or renewal.

QAR Alternatives
 Alternatives to the QAR include:
  • FDA inspection
  • Medicines and Healthcare Products Regulatory Agency (MHRA) inspection
  • Drug Establishment Licence (DEL) reference -- DEL holders may submit a copy of their current establishment licence when activities performed for NHPs and drugs are aligned
  • Audit – An inspection following equivalent GMP guidelines
    (e.g., US cGMP, or PIC/S GMP)
 The GMP Gap Analysis ™
We will perform The GMP Gap Analysis™ audit in accordance with Health Canada and/or FDA for your GMP/cGMP activities. On completion of The GMP Gap Analysis, you will know the compliance gaps, if any, that your processes and procedures have related to the regulatory requirements. In addition, we will recommend specific next steps towards compliance for your processes.