Pharma Regulatory Affairs
Real honest advice on how to overcome the many
bureaucratic obstacles between you and successful commercialization.
What do we mean by Regulatory Affairs?
Regulatory Affairs can be a very broad term applicable to any industry. In our case, we refer to consultancy on how to navigate the many rules and requirements by the likes of EMA, FDA, MHRA, or many national health authorities.
Those rules especially pertaining to successfully placing your medicinal product or medical device on the market and keeping it there.
Like with much else within our industry, these requirements got out of hand.
It’s unnecessarily complex to apply for authorizations or make even simple adjustments. Many innovative companies can easily hit the wall with overengineered regulations.
That is the opposite of value-based healthcare and we decided to fight it.
While we continue to challenge the regulatory landscape with regulators themselves, what we can offer to our customers directly is a genuine counsel on how best skip the bureaucratic hurdles with as little extra cost as possible.
Very much like our core business of pharmacovigilance, the regulatory affairs services within Pharma have become labour-intense and unnecessarily expensive. That doesn’t fly with us, and we strive to reduce the admin burden behind regulatory affairs.
What can we do?
Global Regulatory Affairs Services
Regulatory Document Preparation
and eCTD Submission
•
Communication with
Regulatory Authorities
•
Marketing Authorization Applications
(MAAs) and Transfers (MATs)
•
Marketing Authorization
Variations
CMC Life Cycle Management
•
Global Regulatory Strategy
•
Local Regulatory Representatives
in 150+ Countries
•
Regulatory Intelligence
Around the World
•
+ Ad Hoc Consultancy
in Many Other Areas
In a nutshell, the term “regulatory affairs” refers to submission of documents to regulatory authorities related to your medicinal products on medical devices. The authorities have specified in what way, when, and in what kind of format they want to receive this data. This is basically the main challenge of regulatory affairs and the main reason why the business of regulatory affairs exists.
We can’t influence much what the authorities’ requested document formats look like and whether they really reflect the possibilities of the 2020s (hint: they don’t). What we can influence, however, is what your regulatory strategy will look like and whether or not you end up paying extra for hundreds of unnecessary and expensive admin hours on top what’s already demanded by the authorities.
If you look to place your product on the market or ensure it stays there, you may need a partner to ensure you don’t get stuck in the mud of the cumbersome administrative process.
Whether you need help pulling together the documentation for your Marketing Authorization Application, get through the tedious process of managing Marketing Authorization Transfers or even simple variations, we’re ready to help, and most importantly provide the right advice.
Our objective is always to gauge your current situation, understand your goals,
and come up with the most pragmatic plan how to achieve those.
Local Regulatory Representative
In many markets, you may need to have local legal representation for regulatory affairs. Unless you have an affiliate in that country, it may be best for you to subcontract the activity, and who better than the company offering this service in 150+ countries with highly qualified and experienced partners and with the great added benefit of getting rid of all the unnecessary admin costs thanks to unique automation tools.
Whether legally required or simply preferrable to have in place, the local regulatory affairs representative should be the key contact point between you and the regulatory authority related to variations and other submissions for your product(s) locally. They should know the local language, reside in the country (not always necessary), and have perfect knowledge of the regulatory processes in their country.
Our locally based RA experts can provide local support including but not limited to:
✓ Legally needed role and responsibility
of Local Regulatory Contact Person
✓ Liaising with the Regulatory Authorities
✓ Regulatory Intelligence
✓ Availability as needed
✓ Support with review, implementation
and submission of variation
✓ Local language support and translation
✓ Scientific Advice
✓ Other ad hoc activities
Where can we provide a local regulatory representative?
Europe
Austria
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Kosovo
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Moldova
Montenegro
Netherlands
North Macedonia
Norway
Poland
Portugal
Romania
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
Americas
Aruba
Barbados
Belize
Bolivia
Brazil
Canada
Chile
Colombia
Costa Rica
Curacao
Dominican Republic
Ecuador
El Salvador
Guatemala
Guyana
Honduras
Jamaica
Mexico
Nicaragua
Panama
Paraguay
Peru
Suriname
Trinidad and Tobago
United States
Uruguay
Venezuela
APAC
Brunei
Cambodia
China
Hong Kong
India
Indonesia
Japan
Laos
Malaysia
Mongolia
Myanmar
New Zealand
Papua New Guinea
Philippines
Singapore
South Korea
Sri Lanka
Taiwan
Thailand
Vietnam
CIS
Azerbaijan
Georgia
Kazakhstan
Kyrgyzstan
Russia
Tajikistan
Turkmenistan
Uzbekistan
Mena
Bahrain
Egypt
Iraq
Israel
Jordan
Kuwait
Lebanon
Morocco
Oman
Pakistan
Qatar
Saudi Arabia
Syria
Tunisia
Turkey
United Arab Emirates
Yemen
Sub-Saharan Africa
Benin
Botswana
Burkina Faso
Burundi
Cameroon
Central African Republic
Chad
Democratic Republic of Congo
Djibouti
Ethiopia
Gabon
Gambia
Ghana
Guinea
Ivory Coast
Kenya
Lesotho
Madagascar
Malawi
Mali
Morocco
Mozambique
Namibia
Niger
Nigeria
Republic of the Congo
Rwanda
Senegal
Sierra Leone
South Africa
Tanzania
Togo
Uganda
Regulatory Intelligence
Regulatory intelligence refers to updated information about the legislation, guidelines and practices the regulatory authorities expect from the pharmaceutical companies.
These are set of rules and practices that must be, should be, or can be followed in order to have a pharmaceutical product authorized and marketed in a specific country. For any high-quality regulatory strategy, keeping up to date with relevant global regulations is essentially.
Thanks to our network of regulatory partners in around 150+ countries, you can be sure you’re in a safe place with us when it comes to monitoring regulatory updates around the world’s national regulatory bodies.
But as simple monitoring of websites for any regulatory affairs expert can be a tedious task, being the only genuinely fully digital provider in this space, it would be off brand for us if we didn’t’ find a way to automate this with our existing inhouse developed tools.
So, of course. We can pull data from around the globe with zero human effort and let the regulatory affairs specialists in 150+ countries focus on analyzing any potentially relevant regulatory updates and assessing its impact on our customers.
Code of conduct
We want to create a field worthy of being value-based healthcare and the way to contribute is to provide sincere guidance to Pharma companies in what is our expertise: regulations.
This approach seems to contrast with the standard.
We think it has become normal that “RA consultants” look for ways to spend as much time possible on their tasks all so they could slap more € on their invoice. Unacceptable.
We are fully committed to our promise of always providing honest advice and finding the most efficient and sensible solution for our clients, even when that means smaller payday for us. Part of our core philosophy is the belief that the bureaucracy has become too taxing and burdensome. It would be completely against our nature to add more administrative costs on top of what we view as too much already. With us, you can be sure that our interest is to get you through those hurdles as easily as humanly possible.
What helps us make that happen?
As a modern, fully digital company, it’s once again technology and smart processes. Thanks to these, we can easily avoid the endless pits of admin work most providers find themselves in. There is a limit to what we can do due to regulators’ processes and sometimes obsolete technology used by them, but where we can, we find a way.
We have already fully automated the entire pharmacovigilance system from A-to-Z for our customers and we continue to innovate in other areas of regulatory affairs, using the same approach and tools we used to successfully overhaul the entire concept of pharmacovigilance services.
Let’s have a chat
Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.
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