Regulatory Affairs

Our full range 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.

Dossier Development / Medical Writing

Our medical writers are qualified scientists with PhD degrees in biomedical sciences and experience in pharmaceutical industry, clinical research organizations or academia. Biomapas’ Medical Writers may support you with the preparation of documents required within clinical research, regulatory affairs or for scientific purposes. Our medical writers become an extension of your team by being flexible to your scope, using their expertise to guide you through your clinical data with a view to demonstrating the efficacy of your drug and improving patient safety.

We can prepare documents in accordance with your template and style guide, or use our own templates, in full compliance with national and international regulatory guidelines. All projects undergo thorough scientific, statistical, editorial and quality control review. Regulatory affairs and pharmacovigilance medical writing services include:

  • Full Dossier development
  • Readability User Testing Reports or Bridging Reports (Module 1.3.4)
  • Risk Management Plans (1.8.2)
  • Environmental Risk Assessments (Module 1.6)
  • Quality Overall Summary (QOS) (Module 2.3)
  • Non-clinical Overview/Summary (Modules 2.4/2.6)
  • Clinical Overview/Summary (Modules 2.5/2.7)
  • Module 4 and Module 5
  • Summaries of product characteristics (SPCs) and Package leaflets (PL)
  • Periodic safety update reports (PSURs)

We have been a member of EMWA (European Medical Writers Association) since 2010.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Dossier Pre-Submission Assessment

Dossier pre-submission assessment involves a critical, objective, scientific and written analysis of your medicinal product documentation. Scientifically assessed dossiers lead to faster and easier registration processes and increased speed to market.

Our internal and external experts can perform an assessment of your dossier, identify possible gaps and weak points, propose appropriate solutions and update the parts in need of attention. In particular, we assess the following sections of your dossier:

  • Non-Clinical and Clinical Summaries
  • Overviews (Modules 2.4-2.7)
  • Quality (Modules 2.3 and 3)
  • Non-Clinical and Clinical Safety and Efficacy Data (Modules 4 and 5)

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Decentralised, Mutual Recognition, National Procedures

We have assisted in obtaining over 150 Marketing Authorisations via National procedure in Europe and CIS regions. We were/are involved in more than 25 Marketing Authorisation procedures of medicinal products via Centralised, Decentralised or Mutual Recognition procedures. We provide full scope service of procedure management, starting from booking of slot for Decentralised or Mutual Recognition procedures, dossier development, pre-submission assessment, eCTD compilation and submission to competent authorities, support in preparing responses to deficiencies reported by the Competent authorities, full support during CHMP and CMDh referral procedures, until the granting of Marketing Authorization.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

eCTD and NeeS Compilation

Biomapas provides full support in Electronic Common Technical Document (eCTD) compilation and submission, as well as Non-eCTD electronic Submissions (NeeS). We use the eCTD Office software. Our team is fully prepared for new requirements and to provide services using eCTD format. Such requirement came into force on 1st of January, 2018.

Full scope eCTD and NeeS services include:

  • A full dossier review and eCTD publishing services;
  • Assessment of old dossiers, gap analysis, update of dossier to be compliant and ready for submission;
  • Converting your documents into eCTD/NeeS format;
  • Preparing the Dossiers in eCTD/NeeS for initial submissions/renewals/variations;
  • Managing the life cycle of your product(s).

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Marketing Authorization Holder Service

MARKETING AUTHORIZATION HOLDER SERVICE

Biomapas provides a Marketing Authorization Holder (MAH) service for the registration procedures of medicinal products. This is required then our client is not able to act as the MAH at the time of the procedure initiation. We offer a complete MAH service, including a full Pharmacovigilance system.

MAH TRANSFER PROJECT MANAGEMENT

The MAH transfer can be initiated at the end of the registration procedure. Our Regulatory Affairs team provides full support for the MAH transfer procedure. Upon request of a client, we can remain the MAH for an unlimited period of time.

Biomapas also provides full-scope Marketing Authorization Application procedure management via Decentralised, Mutual Recognition or National procedures.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Medicinal Product Lifecycle Management

Medicinal product lifecycle management is defined as the process of managing the entire lifecycle of the product. This includes its clinical developmentmarketing authorization and the post-authorization activities. As medicinal products that are already marketed change over time, expertise in renewals, variations, and other medicinal product lifecycle management activities is one of the key elements in order to reach company’s business goals. Our experienced regulatory affairs team provides medicinal product lifecycle management service to clients across Europe and former CIS region and offers different solutions acroding to the scope and extent of the project.

FULL LIFECYCLE MANAGEMENT SERVICE

Biomapas full-scope product lifecycle management service includes but is not limited to:

  • Marketing authorization renewal management;
  • Variation management (type IA, IB, II);
  • Labeling support;
  • Non-EU dossier changes/modifications/amendments;
  • Product line extensions;
  • Product status change (Rx/OTC);
  • Sunset Clause management;
  • Advertising and promotional material review.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Regulatory Affairs Support in Europe and CIS

LOCAL REGULATORY AFFAIRS REPRESENTATION

Biomapas provides local regulatory affairs support to clients in both pre-authorization and post-authorization regulatory affairs across Europe and CIS countries. Our full range of Regulatory Affairs solutions are dedicated to delivering the highest quality support, assistance and regulatory approvals for our clients. We employ fast, efficient, and cost-effective working practices.

EXPERIENCE

We have assisted our clients in obtaining over 150 Marketing Authorizations via National Procedures in Europe and CIS regions. During the past few years we have performed more than 1,000 regulatory submissions. We were/are involved in more than 25 Marketing Authorization Procedures of Medicinal Products via Centralized, Decentralized or Mutual Recognition Procedures. Full Biomapas expertise listed here.

GEOGRAPHICAL COVERAGE

The detailed list of our geographical coverage is presented below (office office locations highlighted):

 Europe
Albania Estonia Lithuania Portugal
Austria Finland Luxembourg Romania
Belgium France Macedonia Serbia
Bosnia and Herzegovina Germany Malta Slovakia
Bulgaria Greece Moldova Slovenia
Croatia Hungary Montenegro Spain
Cyprus Italy Netherlands Sweden
Czech Republic Kosovo Norway Switzerland
Denmark Latvia Poland Turkey
CIS Region
 Armenia Georgia  Mongolia  Turkmenistan
 Azerbaijan  Kazakhstan  Russia  Ukraine
 Belarus  Kyrgyzstan  Tajikistan  Uzbekistan

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Medical Devices and IVD Devices

Biomapas provides full scope regulatory affairs services for Medical Devices and In Vitro Diagnostic Devices. This includes:

  • Clinical Evaluation of Medical Devices
  • CE Marking Consulting for Medical Devices and IVDs
  • Guidance on medical device classification
  • Consulting on the European Medical Devices Directives
  • Technical File Preparation for Medical Devices and IVDs
  • Interaction with and documentation preparation for Competent Authorities
  • Clinical Evaluation Reports for Medical Devices

Biomapas also offers Clinical Evaluation and Materiovigilance services on Medical Devices.

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Regulatory Affairs

Our full range 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.

Dossier Development / Medical Writing

Our medical writers are qualified scientists with PhD degrees in biomedical sciences and experience in pharmaceutical industry, clinical research organizations or academia. Biomapas’ Medical Writers may support you with the preparation of documents required within clinical research, regulatory affairs or for scientific purposes. Our medical writers become an extension of your team by being flexible to your scope, using their expertise to guide you through your clinical data with a view to demonstrating the efficacy of your drug and improving patient safety.

We can prepare documents in accordance with your template and style guide, or use our own templates, in full compliance with national and international regulatory guidelines. All projects undergo thorough scientific, statistical, editorial and quality control review. Regulatory affairs and pharmacovigilance medical writing services include:

  • Full Dossier development
  • Readability User Testing Reports or Bridging Reports (Module 1.3.4)
  • Risk Management Plans (1.8.2)
  • Environmental Risk Assessments (Module 1.6)
  • Quality Overall Summary (QOS) (Module 2.3)
  • Non-clinical Overview/Summary (Modules 2.4/2.6)
  • Clinical Overview/Summary (Modules 2.5/2.7)
  • Module 4 and Module 5
  • Summaries of product characteristics (SPCs) and Package leaflets (PL)
  • Periodic safety update reports (PSURs)

We have been a member of EMWA (European Medical Writers Association) since 2010.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Dossier Pre-Submission Assessment

Dossier pre-submission assessment involves a critical, objective, scientific and written analysis of your medicinal product documentation. Scientifically assessed dossiers lead to faster and easier registration processes and increased speed to market.

Our internal and external experts can perform an assessment of your dossier, identify possible gaps and weak points, propose appropriate solutions and update the parts in need of attention. In particular, we assess the following sections of your dossier:

  • Non-Clinical and Clinical Summaries
  • Overviews (Modules 2.4-2.7)
  • Quality (Modules 2.3 and 3)
  • Non-Clinical and Clinical Safety and Efficacy Data (Modules 4 and 5)

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Decentralised, Mutual Recognition, National Procedures

We have assisted in obtaining over 150 Marketing Authorisations via National procedure in Europe and CIS regions. We were/are involved in more than 25 Marketing Authorisation procedures of medicinal products via Centralised, Decentralised or Mutual Recognition procedures. We provide full scope service of procedure management, starting from booking of slot for Decentralised or Mutual Recognition procedures, dossier development, pre-submission assessment, eCTD compilation and submission to competent authorities, support in preparing responses to deficiencies reported by the Competent authorities, full support during CHMP and CMDh referral procedures, until the granting of Marketing Authorization.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

eCTD and NeeS Compilation

Biomapas provides full support in Electronic Common Technical Document (eCTD) compilation and submission, as well as Non-eCTD electronic Submissions (NeeS). We use the eCTD Office software. Our team is fully prepared for new requirements and to provide services using eCTD format. Such requirement came into force on 1st of January, 2018.

Full scope eCTD and NeeS services include:

  • A full dossier review and eCTD publishing services;
  • Assessment of old dossiers, gap analysis, update of dossier to be compliant and ready for submission;
  • Converting your documents into eCTD/NeeS format;
  • Preparing the Dossiers in eCTD/NeeS for initial submissions/renewals/variations;
  • Managing the life cycle of your product(s).

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Marketing Authorization Holder Service

MARKETING AUTHORIZATION HOLDER SERVICE

Biomapas provides a Marketing Authorization Holder (MAH) service for the registration procedures of medicinal products. This is required then our client is not able to act as the MAH at the time of the procedure initiation. We offer a complete MAH service, including a full Pharmacovigilance system.

MAH TRANSFER PROJECT MANAGEMENT

The MAH transfer can be initiated at the end of the registration procedure. Our Regulatory Affairs team provides full support for the MAH transfer procedure. Upon request of a client, we can remain the MAH for an unlimited period of time.

Biomapas also provides full-scope Marketing Authorization Application procedure management via Decentralised, Mutual Recognition or National procedures.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Medicinal Product Lifecycle Management

Medicinal product lifecycle management is defined as the process of managing the entire lifecycle of the product. This includes its clinical developmentmarketing authorization and the post-authorization activities. As medicinal products that are already marketed change over time, expertise in renewals, variations, and other medicinal product lifecycle management activities is one of the key elements in order to reach company’s business goals. Our experienced regulatory affairs team provides medicinal product lifecycle management service to clients across Europe and former CIS region and offers different solutions acroding to the scope and extent of the project.

FULL LIFECYCLE MANAGEMENT SERVICE

Biomapas full-scope product lifecycle management service includes but is not limited to:

  • Marketing authorization renewal management;
  • Variation management (type IA, IB, II);
  • Labeling support;
  • Non-EU dossier changes/modifications/amendments;
  • Product line extensions;
  • Product status change (Rx/OTC);
  • Sunset Clause management;
  • Advertising and promotional material review.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Regulatory Affairs Support in Europe and CIS

LOCAL REGULATORY AFFAIRS REPRESENTATION

Biomapas provides local regulatory affairs support to clients in both pre-authorization and post-authorization regulatory affairs across Europe and CIS countries. Our full range of Regulatory Affairs solutions are dedicated to delivering the highest quality support, assistance and regulatory approvals for our clients. We employ fast, efficient, and cost-effective working practices.

EXPERIENCE

We have assisted our clients in obtaining over 150 Marketing Authorizations via National Procedures in Europe and CIS regions. During the past few years we have performed more than 1,000 regulatory submissions. We were/are involved in more than 25 Marketing Authorization Procedures of Medicinal Products via Centralized, Decentralized or Mutual Recognition Procedures. Full Biomapas expertise listed here.

GEOGRAPHICAL COVERAGE

The detailed list of our geographical coverage is presented below (office office locations highlighted):

 Europe
Albania Estonia Lithuania Portugal
Austria Finland Luxembourg Romania
Belgium France Macedonia Serbia
Bosnia and Herzegovina Germany Malta Slovakia
Bulgaria Greece Moldova Slovenia
Croatia Hungary Montenegro Spain
Cyprus Italy Netherlands Sweden
Czech Republic Kosovo Norway Switzerland
Denmark Latvia Poland Turkey
CIS Region
 Armenia Georgia  Mongolia  Turkmenistan
 Azerbaijan  Kazakhstan  Russia  Ukraine
 Belarus  Kyrgyzstan  Tajikistan  Uzbekistan

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us

Medical Devices and IVD Devices

Biomapas provides full scope regulatory affairs services for Medical Devices and In Vitro Diagnostic Devices. This includes:

  • Clinical Evaluation of Medical Devices
  • CE Marking Consulting for Medical Devices and IVDs
  • Guidance on medical device classification
  • Consulting on the European Medical Devices Directives
  • Technical File Preparation for Medical Devices and IVDs
  • Interaction with and documentation preparation for Competent Authorities
  • Clinical Evaluation Reports for Medical Devices

Biomapas also offers Clinical Evaluation and Materiovigilance services on Medical Devices.

For any inquiry regarding our services, please contact Biomapas Business Development team.

contact-us