Regulatory Affairs

An extension of your RA team that spans all of the EU, CIS & MENA regions.

Timely execution of projects isn’t luck. It takes passion and experience.

Local regulatory experts for Pharma, Biotech and Medical Device companies across Europe, CIS/EAEU, and MENA regions from dossier development to full life-cycle management. Our full range of regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements. Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences.

 

Pre-Authorization

Biomapas’ expertise ranges from developing and executing your regulatory strategy to pave the way for Marketing Approval. By combining our in-house regulatory expertise with scientific know-how, we help you to ask the right questions and to keep the end goal in mind during early development.

Our focus is on enabling you to navigate the landscape of complicated regulations and compliance hurdles and provide you with a clear strategy for successful commercialization. In addition to complicated regulations and compliance hurdles, we also deliver specific support concerning local needs as they are fundamental to any strategic regulatory decision. As an extension of your team, we cooperate with you every step of the way towards Marketing Authorization.

Regulatory Strategy / Gap Analysis

Scientific Advice

Dossier Development/Medical Writing

Chemistry, Manufacturing, and Controls (CMC)

Medical Device Services

Market Authorization

Understanding Agency’s timetables for your product’s assessment and having the right people available helps ensure you meet each requirement and beat timelines.  Following local laws for countries within Biomapas’ reach, we can prepare initial submission packages and documentation and prepare all country-specific templates. Our support includes collecting all essential documents from the sites and documents received from the Sponsor you need for submissions and acting as the primary, direct contact point with local HAs.

An effective project management team that maximizes pace, efficiency, and accuracy of deliverables for the Health Authorities is crucial. Decisions in this phase can determine your product’s future route and affect your marketing and commercialization approach. Comprehension of obtaining the right and formulating effective responses to Agency questions can significantly influence your chances of success. 

Marketing Authorization Applications (EU / EMA)

Marketing Authorization Applications (EAEU)

National Marketing Authorization Applications

eCTD and NeeS Compilation

Medical Device Services

 

 

 

 

 

Post-Authorization

Marketed products are continuously subject to change so, Biomapas’ services continue beyond Marketing Authorization. Partnering with you to ensure you meet Post-Authorization requirements regarding your product’s quality and safety throughout its lifecycle.

Our expertise in optimizing regulatory operations around renewals, variations, and other lifecycle management activities is one of the critical elements to reach your business goals

 

Product Lifecycle Management

Local Regulatory Affairs EAEU/CIS

Regulatory Intelligence

Promotional and Advertising Material Review

 

Geographical Coverage

Medical Devices & IVD

Pre-Authorization

Biomapas’ expertise ranges from developing and executing your regulatory strategy to pave the way for Marketing Approval. By combining our in-house regulatory expertise with scientific know-how, we help you to ask the right questions and to keep the end goal in mind during early development.

Our focus is on enabling you to navigate the landscape of complicated regulations and compliance hurdles and provide you with a clear strategy for successful commercialization. In addition to complicated regulations and compliance hurdles, we also deliver specific support concerning local needs as they are fundamental to any strategic regulatory decision. As an extension of your team, we cooperate with you every step of the way towards Marketing Authorization.

Regulatory Strategy / Gap Analysis

Scientific Advice

Dossier Development/Medical Writing

Chemistry, Manufacturing, and Controls (CMC)

Medical Device Services

Market Authorization

Understanding an Agency’s timetables for your product’s assessment and having the right people available helps ensure you meet each requirement and beat timelines.  Following local laws for countries within Biomapas’ reach, we can prepare initial submission packages and documentation and prepare all country-specific templates. Our support includes collecting all essential documents from the sites and documents received from the Sponsor you need for submissions and acting as the primary, direct contact point with local HAs.

An effective project management team that maximizes pace, efficiency, and accuracy of deliverables for the Health Authorities is crucial. Decisions in this phase can determine your product’s future route and affect your marketing and commercialization approach. Comprehension of obtaining the right and formulating effective responses to Agency questions can significantly influence your chances of success. 

Marketing Authorization Applications (EU / EMA)

Marketing Authorization Applications (EAEU)

National Marketing Authorization Applications

eCTD and NeeS Compilation

Medical Device Services

Post-Authorization

Marketed products are continuously subject to change so, Biomapas’ services continue beyond Marketing Authorization. Partnering with you to ensure you meet Post-Authorization requirements regarding your product’s quality and safety throughout its lifecycle.

Our expertise in optimizing regulatory operations around renewals, variations, and other lifecycle management activities is one of the critical elements to reach your business goals

Product Lifecycle Management

Local Regulatory Affairs EAEU/CIS

Regulatory Intelligence

Promotional and Advertising Material Review

Geographical Coverage

Medical Devices & IVD

RA Professionals

Countries Covered

%

Of Staff Are Pharmacists

Extension of your team

We aspire to work with you and not for you, complementing capabilities and internal organization.

Inhouse Workforce

We are not another middleman, working through our own workforce across Europe, CIS & MENA

Emerging Markets

The partner of choice to extend your commercialization activities in CIS/EAEU & MENA countries.

Blog

Pharmaceutical opportunities in the CIS & EAEU region.

The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. This article shares insight into region peculiarities, legislation changes and experience in RA and PV in CIS.

A partner that is dedicated to you and understands the challenges you face. 

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Olga Bernardova

Olga Bernardova

Head of Global Regulatory Affairs

Olga Bernardova has over a decade of regulatory affairs experience. As a proven leader in regulatory affairs, Olga Bernardova has in-depth experience at regional and international level regulatory activities guidance and implementation.