WHO-GMP Certification Support
We guide our clients through difficult issues, bringing insight and judgment to each situation. Our innovative approaches create original solutions to our clients’ most complex domestic & multi juristictional deals and disputes. By thinking on behalf of our clients every day, we anticipate what they want.
Our hands-on approach ensures your facility meets all necessary quality and safety requirements, minimizing the risk of non-compliance.
We provide comprehensive support, from conducting gap analyses and preparing essential documentation to guiding internal audits and regulatory inspections. Our goal is to streamline the certification process, helping you achieve and maintain compliance with WHO-GMP standards efficiently and effectively.
Why Is WHO-GMP Certification Important?
WHO-GMP certification ensures your pharmaceutical manufacturing facility adheres to international standards of safety, quality, and consistency. It is a critical requirement for exporting medicines to many countries.
Benefits of Certification:
- Ensures product quality and safety
- Enables international market access
- Builds trust with regulators and consumers
- Reduces the risk of non-compliance penalties
Our Step-by-Step Process to Achieve WHO-GMP Certification
Why Trust ComplyPharma for WHO-GMP Certification Support?
What is the purpose of regulatory approvals?
To ensure products are safe, effective, and meet quality standards before reaching the market.
Why is proper documentation important?
It provides accurate information needed for regulatory review and helps prevent delays or rejections.
What is the difference between paper and electronic submissions?
Paper submissions use physical documents, while electronic submissions are digital, faster, and more efficient.
What are the key steps in regulatory submission?
Data collection, document structuring, quality review, submission preparation, and responding to queries.
How do global regulatory authorities differ?
Each authority has its own guidelines, formats, and processes based on regional regulations.
Why is certification important for manufacturing facilities?
It proves the facility meets international quality standards, allowing products to enter global markets.
What happens if a submission is rejected?
The issues must be addressed, additional data may be provided, and the submission can be resubmitted.
