Quality assurance
and regulatory affairs
Batch release, procedures, risk management and regulatory filings: a quality system that holds up day to day and during inspections.
Standards EMA-Annex 1 · GMP · ICH Q9 · Health Canada · FDA · ISO 9001 · HACCP
Challenges we solve
Are you at one of these stages?
01
Batches to release
You need reliable batch release that doesn’t hold up production.
Let’s talk about this challenge
02
Procedures to revise
Your procedures are incomplete or outdated, and deviations keep piling up.
Let’s talk about this challenge
03
A license or registration
DEL, MDEL, DIN or NPN: your application has to be complete the first time.
Let’s talk about this challenge
04
Controlled substances
Your activities require a Qualified Person in Charge (QPIC) recognized by Health Canada.
Let’s talk about this challenge
We handle quality assurance and batch release, write and review procedures (SOPs and work instructions), set up change control, CAPA and root cause analysis, and review quality agreements with your partners.
On the regulatory side, we prepare the Site Master File (SMF), establishment licenses (DEL, MDEL) and drug (DIN) and natural health product (NPN) registrations, and we provide QPIC services for controlled substances.
What you get
Results you can show.
Batch release and quality assurance follow-up
Procedures (SOPs and work instructions), written or revised
Change control, CAPA and root cause analysis
Quality agreements with your partners
The Site Master File (SMF)
License (DEL, MDEL) and registration (DIN, NPN) applications
What the service includes
The common core for every industry we serve.
Service sheet
Quality assurance and EMA-Annex 1 compliance
Page 1 of 1
- 01EMA-Annex 1 complianceContamination control strategy (CCS) and quality risk management (QRM)
- 02Quality assurance and batch release
- 03Procedure writingSOPs and work instructions
- 04Operations and health and safety support
- 05Change control, CAPA, failure mode and effects analysis (FMEA)
- 06Root cause analysis (RCA)
- 07Annual product review (APR), IT and data integrity, process capability
- 08Risk management, assessment and mitigation, impact study (RAPA, GAPA): FMEA, ICH Q9, ATEX, FMD-135
- 09Industry 4.0Digitization, data collection and integrity, ERP, SAP
Approved by
The PBE Expert team
Featured
GMP compliance,
an evolving framework
Dr. Aziz Chraibi, president of PBE Expert and a Health Canada scientific expert since 2007, holds a conviction the whole team shares: compliance is built day by day, for a more resilient pharmaceutical industry.
September 2024
Our awardsBy industry
Every industry adds its own requirements. Here is what comes on top of the common core, industry by industry.
Pharmaceutical4 items
- QPIC services for controlled substances: cannabis (THC), opiates
- Cannabis producer licenses, DIN (THC) and NPN (CBD) registrations
- Regulatory affairs: drug (DIN) and natural health product (NPN) registration
- Drug Establishment Licences (DEL) and Medical Device Establishment Licences (MDEL)
Biotechnology and vaccines2 items
- Temperature and humidity mapping: cold rooms, warehouses, freezers, incubators, ovens and depyrogenation ovens, autoclaves, freeze dryers
- Regulatory affairs: drug registration (DIN) and Drug Establishment Licences (DEL)
EU-GMP therapeutic and medical cannabis4 items
- QPIC services for controlled substances and cannabis (THC) vault management
- Cannabis producer licenses, DIN (THC) and NPN (CBD) registrations
- Regulatory affairs: drug (DIN) and natural health product (NPN) registration
- Drug Establishment Licences (DEL) and Medical Device Establishment Licences (MDEL)
Hospitals and pharmacies4 items
- QPIC services for controlled substances: cannabis (THC), opiates
- Predictive, systemic and preventive maintenance plan
- Metrology: calibration program and traceability
- Temperature and humidity mapping: cold rooms, warehouses, freezers, incubators, ovens and depyrogenation ovens
Fine chemicals and APIs1 items
- Regulatory affairs: drug registration (DIN) and Drug Establishment Licences (DEL)
Food4 items
- Risk management, assessment and mitigation, impact study (RAPA, GAPA): FMEA, ATEX, NFPA
- Predictive, systemic and preventive maintenance plan
- Metrology: calibration program and traceability
- Temperature and humidity mapping: cold rooms, warehouses, freezers, microwaves (thawing food before processing)
In practice
One project as an example.
Frequently asked questions
What people ask us.
Do you provide QPIC services?
Yes, for controlled substances and precursors, with a Qualified Person in Charge recognized by Health Canada.
Do you prepare the Site Master File?
Yes, along with establishment license applications (DEL, MDEL) and DIN and NPN registrations.
Can you manage our quality assurance day to day?
Yes: batch release, procedures, change control and CAPA.
Let’s talk about your project.
A new site, an expansion, an inspection to prepare for: describe your project and one of our experts will get back to you.