India is a major pharmaceutical exporter and one of the largest providers of generic drugs. As high-quality affordable medicines are manufactured in India, India has earned the name “pharmacy of the world”. Additionally, a highly skilled resource pool and low labour costs are an added advantage for India. To export the drug, certificate of pharmaceutical product will be required to register the drug in the importing country.

What is certificate of pharmaceutical product?

Certificate of pharmaceutical product (COPP) is required for global marketing approval of a drug. It is usually issued by the National Health Authorities of the exporting country to be used by the importing country. This certification is issued by the exporting country to demonstrate the drug complies with industry quality guidelines and WHO regulations. Moreover, COPP certification indicates the drug is of high-quality and is safe and effective. Notably, this certification is usually issued for a single product not for the pharma company or manufacturing process.

This certificate is issued in a format recommended by the WHO. Only after evaluating the efficacy, quality, and safety of the pharmaceutical product, the certificate is issued. It establishes the status of the drug in the exporting country. To market a drug in another country, the COPP is required to register the drug in the importing country. Thus, COPP is required for registration, licensing, authorization, and license renewal purposes in the importing country.

Thus, to register, secure licenses, market drugs, and even renew licenses in importing countries, COPP certification will be required. The certificate of pharmaceutical product has to be procured in India to export pharmaceutical products to other countries. Hence, there is a high demand for COPP certification service in India. Our COPP certification service makes the certification process hassle-free.

Necessary documents required for obtaining certificate of pharmaceutical products

These are some of the documents that have to be submitted along with the application for COPP:

• Covering letter
• Manufacturing license
• Plant master file
• Validation plans and formula records
• GMP Certificate
• Product details
• Labelling and packaging information
• Product registration certificate
• Free sale certificate
• Clinical trial data (if applicable)
• Pharmacovigilance data and record
• Stability Data
• Power of attorney (if using a representative)

This list is only an overview of the documents required. For a detailed list of documents, feel free to get in touch with us. Additionally, we provide document preparation support. Avail our document preparation service to easily prepare the necessary documents within the stipulated deadline.

Fill out the form below to secure your COPP in a hassle-free manner

Why should you apply for certificate of pharmaceutical product?

• COPP certification provides access to foreign markets. This certificate will be required to register drugs in foreign countries. It helps streamline the import process.
• To obtain COPP certification, regulatory and GMP guideline compliance are mandatory. Ideally, high-quality, safe, and effective drugs are COPP certified. Thus, patient safety and security are ensured.
• Certificate of pharmaceutical product demonstrates the manufacturer’s commitment to patient safety. Thus, the certificate increases trust on the manufacturer, thereby providing a competitive edge.
• COPP certification will reduce obstacles in the import process.
• COPP certification increases the credibility of the drug in the global market. Thus, COPP leads to global market approval.

How will Pharmadocx Consultants help you secure the COPP certificate?

1. We will help you fill up the application and guide you through the entire application process.
2. We will help you prepare the necessary documents and collate them per application requirements.
3. Our staff training sessions will help your technical personnels manufacture the drugs per GMP guidelines.
4. We will provide precise guidance for modifying the manufacturing facility and equipment to make them GMP complaint. Additionally, our team of experts will conduct mock audits to help you prepare for the COPP inspection. Furthermore, we not only identify lapses but also provide corrective actionable next steps.
5. Our team will act as a bridge between you and the regulatory officials. By acting as a liaison, we help ensure easy communication between the two parties. Moreover, we help interpret regulatory feedback and assist in preparing responses.
6. Our team will track the application process. Additionally, we will provide real time updates.
7. We will designate a dedicated expert to assist you throughout the process. We will provide assistance till you successfully secure the COPP.

Pharmadocx Consultants: COPP certification service

Avail our COPP certification service for a seamless experience. Our team of experts will ensure you obtain your certificate of pharmaceutical product in a hassle-free manner.