Registration

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Product Registration

The primary responsibility of all government drug regulatory agencies around the world is to ensure that all products provided to citizens meet acceptable standards of quality, safety and efficacy.
FarmaSino supports these regulations and assists governments with this process on behalf of our distributors to meet the health needs of their populations.
FarmaSino has registered hundreds of pharmaceuticals and health products worldwide. Our experienced registration department handles all matters related to the registration of our products.
Our dealers rely on our experience and competent staff to complete product registration effectively and efficiently. Whether registration takes months or even years, we will hold on to our distributors until the product is approved and imports of our products begin.
As a highly detail-oriented process, product registration procedures and requirements vary from country to country.
Whether registering one of our more than 400 medicines, our extensive and growing range of supplements, a medical device from one of our three brand divisions, or our range of veterinary products, we’ll keep an eye on the entire process.

STEP 1
REGISTRATION PROCESS

Manufacturing Agreement
The terms, conditions, and specifications of the FarmaSino-Distributor relationship are clearly stated. Prior to finalizing an agreement, FarmaSino must approve the client.

However, we realize that small-bulk distributors are equally entitled to the privileges of our large-bulk distributors. To this end, we work closely with our customers to help them grow their markets. FarmaSino also believes in conducting business in a transparent manner as reflected in our relationships with our customers.
STEP 2
REGISTRATION PROCESS

Factory Inspections
Some countries require a facility inspection by their MOH officials, unless previously inspected, in order to complete product registration.

Factory inspections are required by many countries to ensure that facilities producing the medicines and healthcare products consumed by their citizens are safe and effective. Other countries only require specific documentation proving safety and quality standards. FarmaSino supports such inspections and has vast experience in working with inspectors to make sure requirements are met.
STEP 3
REGISTRATION PROCESS

Dossier Preparation
FarmaSino begins preparing all necessary documents according to the importing country’s requirements. Dossiers and other documents needed for registration are vital to registering healthcare products in any country.

FarmaSino’s registration department has vast experience in successfully registering hundreds of our products worldwide. Health ministries around the world know that when FarmaSino products are being registered, the process will be efficient and accurate.
STEP 4
REGISTRATION PROCESS

Packaging Design
Packaging is designed according to both market demands and distributor requirements. Excellent packaging is one of the most important aspects in marketing our products.

FarmaSino brands are packaged with the best materials and according to the highest standards. Our customers can also package our products according to their specifications and requirements.
STEP 5
REGISTRATION PROCESS

Sample Production
Samples are required by most countries for testing in order to complete product registration. Samples are produced according to the standards (USP, BP, etc.) required for product registration.

We pretest samples to ensure their purity and uniformity, the two most important criteria for sample testing. FarmaSino has gained a reputation with health ministries around the globe, often foregoing standard sample submission requirements.
STEP 6
REGISTRATION PROCESS

Registration Submission
After all documents have been prepared and samples produced, the healthcare product(s) are submitted for approval.

It is vital to the success of not only the product(s) being registered, but also all future products to be registered by FarmaSino, that accuracy is absolute. One small error can result in the failure of product registration, costing FarmaSino and our customers time and money. For this reason, we meticulously verify the accuracy of all documents and samples submitted.
STEP 7
REGISTRATION PROCESS

Registration Approval
Successful product registration is necessary to import our products.

FarmaSino has successfully completed the registration process with numerous health ministries, agencies, and administrations around the world. Our products can be found on 4 continents for one important reason: we are excellent at what we do. FarmaSino has a global reputation for quality and value…from Asia to Africa, customers and consumers rely on our ability to successfully register our products around the world.

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Facility inspection

Facility inspections are internal audits that identify hazards and ensure that corrective actions are taken. They are important for all businesses, regardless of size.

Inspection and licensing of pharmaceutical manufacturing facilities on a GMP-compliant basis is an important component of pharmaceutical control. FarmaSino supports World Health Organization initiatives aimed at improving inspection technology and increasing inspection frequency for the common good of society.
In addition to frequent in-house and third-party inspections for quality assurance purposes, we regularly host government inspectors from abroad to obtain their approval when preparing to enter new markets.
Government inspectors represent the enforcement arm of the state’s drug regulatory agency. Its function is to ensure that manufacturers comply with all licensing regulations, in particular GMP. The purpose is to provide authorization for the manufacturer’s products to be imported into the country where the inspector is located.
The first objective involves the continuous inspection of production and control activities in accordance with GMP guidelines issued by the World Health Organization or nationally determined requirements.
The second requirement verifies that the production and quality control procedures employed in the manufacture of a specific product are performed correctly and comply with the data provided in the relevant license application. Inspections also depend on other factors such as national legislation and regulations in the country where the inspector is based and/or available resources.
While inspection standards and procedures vary from country to country, the results do not. FarmaSino products have successfully obtained approvals from ministries of health and agencies from Australia to Africa, the Middle East to Asia.
We realize that our company’s future depends on our continued product improvements and market expansion. Facility inspections are our top priority and their results reflect our policy of continuous improvement and meticulous attention to detail.

Documentation

Proper documentation is critical in nearly every aspect of the pharmaceutical industry. Whether it’s product registration, factory inspections or in-house quality control, FarmaSino uses the latest technology to simplify and process information.

All facilities have the latest Good Manufacturing Practices (GMP), CE, TUV and/or ISO certificates reflecting high quality standards and WHO rules and regulations.

Necessary product registration documents such as Certificate of Pharmaceutical Products (COPP), Free Sales Certificate (FSC), Certificate of Origin (COO) and Marketing Authorization are among the many documents that our registration department regularly submits for registration purposes.

Likewise, technical documentation is repeatedly checked for consistency and accuracy for internal quality control purposes and in preparation for inspections.

FarmaSino is highly specialized in export processes and has extensive experience in product registration documentation. Our customers realize the value of signing up for our products – the value of quality, time and reliability.

FSC (Free Sale Certificate)pharmasino2024-07-29T06:30:03+00:00

FSC (Free Sale Certificate)

A certificate of free sale reflects the quality of the product and is suitable for placing on the market, but does not guarantee that the product will be sold in the country of origin.

COPP (Cert. of Pharmaceutical Product)pharmasino2024-07-29T06:31:05+00:00

COPP (Cert. of Pharmaceutical Product)

The drug certificate describes the marketing status of the product in the country of origin. It also declares that the facility and products comply with GMP and periodic inspection requirements. This document is also called a WHO certificate.

COA (Certificate of Analysis)pharmasino2024-07-29T06:31:32+00:00

COA (Certificate of Analysis)

A Certificate of Analysis is a document that lists the ingredient formula, the amount of each raw material and ingredient, and the test results that prove the purity of the drug product.

ISO (International Standardization)pharmasino2024-06-05T15:22:03+00:00

ISO (International Standardization)

The ISO family of standards is implemented by the International Organization for Standardization and national standards bodies to ensure that products and facilities comply with acceptable quality management systems.

CE (European Conformity)pharmasino2024-06-05T15:09:17+00:00

CE (European Conformity)

CE certification and marking of medical supplies and medical diagnostic tests reflect that such products comply with EU safety and health requirements. The certification also confirms that an appropriate quality assurance system is adopted and implemented.

GMP (Good Manufacturing Practice)pharmasino2024-06-05T15:19:32+00:00

GMP (Good Manufacturing Practice)

Oversee Good Manufacturing Practices to ensure record keeping, personnel qualifications, sanitation, cleaning, equipment validation, process validation and complaint handling meet or exceed internationally recognized standards and follow World Health Organization protocols.

Pharmaceuticals

Supplements

Medical Devices

Veterinary

Registration

Product Registration

Manufacturing Agreement

Factory Inspections

Dossier Preparation

Packaging Design

Sample Production

Registration Submission

Registration Approval