REGULATORY

Services

Regulatory

As the largest healthcare contract manufacturer in the Asia-Pacific region, GMP has teams based locally in our Sydney, Auckland and Beijing offices, who are able to give expert advice on a broad range of requirements including those issued by TGA, Medsafe and SAC. Through our highly qualified Regulatory Affairs teams, we offer our clients expert consultation over the full scope of regulatory compliance.

  • Regulatory compliance with TGA and FSANZ
  • Expertise in regulatory compliance with Chinese GB standards
  • Label compliance
  • Preparation of Registration Dossier for international markets
  • Export certification
  • Import permits
Regulatory documentation and review

Other Regulatory Services

Technical documents

The technical documents required by regulatory bodies can be extremely difficult to source, time consuming to prepare and hard to understand. GMP can take the hassle out of compiling technical documents so you can concentrate on what you do best, selling manufactured products.

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China import permits

China is one of the most important markets in the world today. Understanding China and the policies of the government is crucial to doing business with China. GMP has an office in Beijing and understands China, the people and regulations better than any pharmaceutical contract manufacturer.

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Free sale certificate

As a GMP manufacturer, GMP Pharmaceuticals is able to supply a free sale certificate where applicable to goods manufactured by us, which clearly states that the product manufactured is compliant, safe and legally allowed to be sold.

GMP certificate

Because GMP Pharmaceuticals manufactures products under GMP guidelines, we are also able to provide the certificate that assures compliance with good manufacturing processes.

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Awards

2019: Supreme Business Excellence Award (South & East) - Westpac Auckland Business Awards

2019: Excellence in International Trade - Westpac Auckland Business Awards