Pharma Regulatory & Registration

Over the past 20 years, we have gained extensive regulatory and registration experience in Latin America, Asia, Russia/CIS, the US, Middle East, and Europe. We worked in various segments such as Pharma/Rx, Consumer health, MD, FS, Cosmetics, etc.

Below are our service offerings:

a. Country registrations learn how to register your products in other countries here

b. Registration by Pharma Segment – click here to select the segment you need

c. GMP Audit/Certificate – learn how to get GMP hassle-free here

d. Bioequivalence Studies (BE Studies) – see if you need them here

e. Pharmacovigilance – read about it here  

f. Clinical Studies – see how we can assist you here

g. Climate Zone Studies – find the right zone here

h. CTD Dossier Files – learn how to create them here

i. Importance of Pharma Regulatory Processesread here

Product Registration
Figure: Regulatory/Product Registration

a. Country registrations – learn how to register your products abroad here

We are regulatory experts in the regions and countries below. Click on the country of your interest to learn about registration of Pharma/Prescription, Consumer Healthcare Drugs/OTC Drugs, Medical Devices, Food Supplements/Nutraceuticals, and Cosmetics.

Select the country of your interest and read about everything you need for registration of Pharma/Prescription, Consumer Healthcare Drugs/OTC Drugs, Medical Devices, Food Supplements/Nutraceuticals, and Cosmetic products.


b. Registration of Pharma Segments

Pharma Regulatory
Figure: CPC Pharma Regulatory
  • International Registration of Pharma and Prescription drugs
    • For the last decade, we have supported our clients in international regulatory and registration for Pharma and Prescription drugs
    • Our expert know-how ranges from Registration & Regulatory topics to GMP Audits & Inspection, Pharmacovigilance, Bio Equivalence Studies, Clinical Studies, Climate Zone Studies, and assembling and upgrading CTD registration dossiers/files from local regulatory documents.
    • We are regulatory experts in Latin America, Europe, US/Canada, Asia, Middle East as well as in Russia and CIS countries and the new EAEU members. 
    • If you are not sure whether your product will be considered a prescription drug in a specific country, get more information here.  
  • Consumer Healthcare Drugs/OTC Drugs
    • We have supported many leading global OTC companies with a product development pipeline for Europe and Emerging Markets.
    • Our expertise includes years of experience in registering Consumer Healthcare drugs in Asia, Latin America, CIS/CEE, and Europe.
    • If you want to check if your product can be registered in this segment in a country of your selection, please contact us here.
  • Medical Devices
    • We can help you to register your medical devices and clarify the regulations in the country you want to enter. Ask us here.
    • With our guidance, you can expect an easy market entry
    • Our team of experts has exceptional experience in registering Medical Devices across the globe  
  • Food Supplements/Nutraceuticals 
    • With our support, the registration of your Food Supplements/Nutraceuticals will be facilitated regardless of the country Contact us here to learn more.
    • Our expert team’s 20+ years of experience will guide you through the registration process
    • Our know-how includes countries in Asia, Latin America, CIS/CEE, and Europe.
  • Cosmetics – are products that can only be used externally and have the purpose of enhancing or changing the skin.
    • Cosmetics registration does not always follow the rules of other segments. Contact us here to learn what documents you will need.
    • We have worked on more than 50 Cosmetic projects over the last six years.
    • With guidance from our experts, our clients were able to successfully register their cosmetic products in various markets.

c. GMP Audit/Certificate – learn how to get GMP hassle-free here

GMP Audit/Certificate
– Over the last decade we have been supporting clients to assist them in receiving GMP certificates regarding EU GMP, Russian GMP, ANVISA GMP, FDA GMP, etc.
– Different governments have different rules on their GMP standards. We understand the differences and commonalities in the GMP systems from Asia to Latin America to Russia/CIS and Europe.
– During a specific 4-5 day GMP Audit, we will be able to give you the full understanding of the GAPs, timeframe and costs associated with receiving e.g. EU GMP standards for your factory

d. Bioequivalence Studies (BE Studies) – see if you need them here

Bioequivalence Studies
– Over the last few years, we have conducted many Bioequivalence Studies (BE Studies) for our clients alongside registration processes in Latin America, Asia, and Russia/CIS
-Moreover we have supported many clients in government negotiations during registration processes to avoid BE studies and save significant costs.
-From our many years’ experience in regulatory processes and our long-term working relationships with the Ministry of Health (MoH) in different countries across the globe, we can help lower the cost & time for BE studies during market entry projects.

e. Pharmacovigilance – read about it here

Pharmacovigilance
– In a number of countries, we have taken over the Pharmacovigilance for drugs from different clients e.g. Mexico, Russia and Europe
– Year by year we support clients to set-up or improve their SOPs. Furthermore, we can be your official trusted partner for batch release, including being the responsible pharmacist concerning the government of EU countries
– We have been setting up Pharmacovigilance Systems in Asia, Latin America and Europe for over 15 years

f. Clinical Studies – see how we can assist you here

Clinical Studies
– Clinical Studies standards can vary greatly between countries, but with our experience in multiple global markets, we can reduce cost and time to a minimum for our clients.
– Utilizing our global network and connections we have been able to reach agreements with the MoH in several countries to avoid setting up clinical studies during certain specific registration processes.
– Over the last 15 years we have conducted many clinical trials for our clients in order to receive registrations. To date we have completed clinical trials in Russia, Ukraine, Mexico, Europe, China, Philippines, India, Thailand, etc.

g. Climate Zone Studies – find the right zone here

Climate Zone Studies
– Market Entry in Asia and Latin America may require climate zone 4b studies. We support our clients in local climate zone studies, which can be used for international marketing in other countries
– Our latest market research has shown that in many cases we have been able to collect climate zone data in Asia and Latin America up to two times faster compared to conducting them in Europe
– We help clients to generate an international registration strategy, which includes how to reduce costs and time needed to conduct e.g. 4b climate zone studies

Figure: CPC Regulatory and Registration Services
Figure: CPC Regulatory and Registration Services

h. CTD Registration Dossier files – learn how to create them here

CTD Registration Dossier files
– For international market entry, the CTD (COMMON TECHNICAL DOSSIER) and the ACTD (ASEAN COMMON TECHNICAL DOSSIER) registration dossier files play an important role. 
– We are experts in transferring your local registration dossier/file from Russia, China, Ukraine, Brazil, Mexico, Indonesia into CTD structure. 
– We have supported many clients in generating an international regulatory strategy, including how to develop CTD standard registration files.

i. Importance of Pharma Regulatory Processes

Since the Pharma Regulatory and registration process is linked to the development of new products, this process represents the first essential step to successfully enter a new market. Therefore, the first step in ensuring the success of pharmaceutical companies depends on gaining the marketing authorization approval from the regulatory body for their Pharma and OTC productsPharma Regulatory in general is a decisive element that enables the commercialization of new healthcare products. Procedures can vary widely between countries, as requirements are country-specific. Regulatory professionals and local regulatory know-how take on an important role right from the beginning of the development of pharmaceuticals and throughout the lifecycle of the product.

 Pharma Regulatory in Emerging Markets

Due to the fast growth of the pharma and OTC industry in Emerging Markets, there is a need for rapid adaptation. The regulatory conditions of pharma emerging markets like Russia, Brazil and other markets are constantly being updated, as improvements are still needed. For example, during the lifecycle of a single product, Emerging Markets can experience regulatory updates and significant changes in the registration processes. Additionally, regulatory procedures and communication with local authorities is not always clear and straightforward in these markets.

CPC offers the most up-to-date information on regulatory changes and on local networks in the global pharma industry. We will gladly assist you in registering your pharma products, and guaranteeing your company a speedy market entry.

Challenges Regulatory
Figure: Challenges of Pharma Regulatory in Emerging Markets

Regulations governing the healthcare industry have been designated by governments to protect public health, and before companies can pursue success in the pharma business, they will have to meet these regulatory requirements. Regulations are diverse and country specific, and therefore, a comprehensive international Regulatory strategy is essential in order to successfully launch new products onto the market.

Today´s dynamic Pharma Regulatory environment demands high expertise and knowledgeable partners who can help you ease the way to success. Chameleon Pharma Consulting has developed a method to help you answer all your regulatory questions and launch your products onto the market. We especially support you in increasing your pharma and consumer health product portfolio in Emerging Markets.

Pharma Regulations represent a process in the area of public health which is developed by governments in order to protect consumers´ health. All pharma and OTC companies need to meet these specific governmental requirements to get new products approved. Pharma Regulations are involved in every stage of the drug development process. The development of new OTC and Rx products constantly brings with it changes in governmental regulations, documentation requirements, and clinical trial procedures which should be addressed from an international perspective. The pharma market is complex and not only is it continually changing but also the corresponding regulations. Due to these on-going changing rules on Pharma Regulatory around the globe, it is advised to have the latest information on current modifications and upcoming changes.

We are the Experts:

All of our Consultants have up-to-date knowledge about current legislations, regulatory requirements and registration processes in Europe and Emerging Markets, as well as a fundamental understanding of how to interpret these regulations correctly.

We operate in various global segments, such as Consumer Health Care, Medical Devices, Rx, OTC and Cosmetics. Our services include the coordination and management of all regulatory processes and submission plans. At Chameleon Pharma Consulting, we provide our clients with pharmaceutical experts who have the background to assist you in drug registrations all over the world.

If you would like to continue your journey through Mature & Emerging Markets (specifically Brazil, Russia, and Mexico) in regards to Regulatory affairs and Registrations, please click below.

Pharma Regulatory in Mature Markets

Mature markets, such as Europe, Japan and the US, have well-established healthcare systems and are urging for synchronization of procedures; for instance, they have developed a Common Technical Document which aims to standardize technical requirements for the registration of new drugs.

Three Regulatory Bodies in the Emerging Markets

Brazil

The Registration process of drugs in Brazil has to be aligned to the regulatory scheme of the National Agency of Sanitary Surveillance (ANVISA). ANVISA was founded in 1999 and is responsible for the regulation of healthcare related products. ANVISA approves Product Registration Dossiers (PRD) and is responsible for the regulation of several public organizations in the healthcare sector. Special attention should be paid to the submission of PRDs to the regulatory agency as inconsistencies often lead to time-consuming and costly registration procedures, which may jeopardize the market entry of new products.

The approval of new products by ANVISA is based on the review of the Product Registration Dossier (PRD). The PRD is a compilation of legal and technical documents which are specific for each type of product. The PRD is submitted to ANVISA which consequently approves the request if the documents support efficacy and safety of the product. Once the approval is obtained, prices are set and product importation can take place.

Challenges to get regulatory approval in Brazil:

  • Process is complex and confusing at times
  • Language barriers
  • Lack of local knowledge (often delays the approval of the product)

It is important to have a reliable partner who can help you navigate this procedure.

We are happy to assist you during the entire registration process, beginning with the application for your product, until the final launch. All our CPC experts have a minimum of 20 years’ experience in the global pharma industry, including the Brazilian market.

Russia

The registration process in Russia can be quite complicated and sometimes problematic for foreign manufacturers. Product testing is a fundamental precondition of getting new products launched. First, there are preclinical studies needed to collect data for new treatments. These are required in order to create a registration dossier for clinical trials in the Russian Federation. As its own national standardized tool, Russia, as other European countries, uses this method for determining product safety and efficiency.

Pharma Regulatory in Russia is carried out by the National Centre of Pharmaceutical Products Expertise (FGU). The process of Pharma Regulatory goes through several institutes and departments. Additionally, the Pharma regulatory environment in Russia has changed significantly over the last years and more and more changes are expected to occur in the following years. As a result, Rx and OTC companies should be aware of the up-to-date regulations and be able to adapt, assuring them an edge over companies without this capability.

Furthermore, as a result of the Russia Pharma2020 Strategy which aims to modernize the pharmaceutical industry in Russia, the government is expecting to substitute 50% of all generic drugs with domestic alternatives by 2017. The Russia Pharma2020 Strategy also includes a plan for manufacturing 50 % of all drugs domestically by 2020, which will make it more difficult for foreign companies to complete the registration process.

Challenges to get regulatory approval in Russia:

  • Process is complex and confusing
  • Language barriers
  • Governmental regulations are changing
  • Country specific requirements are difficult to understand

It is important to have a reliable partner who can help you comply with the current Russian regulations.

Our Experts can support you and your company successfully throughout your registration process and market entry into the Russian market.

 

Mexico

In February 2005, COFEPRIS implemented renewals of drug registrations in the Mexican Pharma Market. Rx and OTC products in Mexico are governed by the Commission for the Protection against Sanitary Risk (COFEPRIS) and must be approved before they are commercialized in the country. The assessment of the application is carried out by COFEPRIS regulatory experts. At times, regulatory experts fail to understand the nature of documents coming from Europe and other countries, which may lead to delays in the approval process. Therefore, having experience when dealing with imported RX and OTC products, as well as knowledge of local requirements, are essential factors for companies striving to get their products into the Mexican market. Further, COREFPRIS has established new registration procedures for Fast Track registration of Consumer Health and Pharma products:

  • Private organizations have been authorized by COFEPRIS to pre-review PRD
  • COFEPRIS has recognized GMPs from specific countries
  • COFEPRIS has signed equivalency agreements to expedite registration of products already registered in specific countries.

CPC has a long-standing network acquired through engagement with several projects in Mexico. We are happy to help you with your international strategy and are here to make your market entry easier into the Mexican Pharma Market.