Scientific and CTD Dossier Writing

Development

Advanced Therapy Medicinal Product (ATMP) Clinical Trial Applications (CTA) CMC Product Development CMC Regulatory support Development Strategy Drug Development Consulting & Strategy Early & Expanded Access Programs in France EMA/HTA Parallel scientific advice European Investigational Medicinal Product Dossier - EU IMPD Orphan Drug Designations (ODDs) Paediatric Investigation Plans (PIPs) Preparation, writing and redaction of clinical study reports PRIME EU and Breakthrough Therapy Designation US Registration Strategy Scientific Advice & Interaction with Health authorities Scientific and CTD Dossier Writing Strategy

What is Scientific Writing?

Scientific/Medical Writing is about preparing and compiling the scientific and technical regulatory documents required during development, registration, launch and lifecycle management of medicinal products/medicines. BlueReg can provide you with Scientific Writing services of high quality to support you through this entire regulatory application process.

The highly qualified and experienced team of scientific writers at BlueReg offer strategic scientific and medical writing and reviewing services for Chemistry Manufacturing and Controls (CMC), non-clinical, clinical, pharmacovigilance and regulatory documents, ensuring key messages supporting your regulatory strategy are captured in a clear and concise manner, in high-quality and technical documents.

By combining solid scientific and regulatory expertise/experience, our team of scientific and medical writers team can support you in a wide range of services in different therapeutic areas and for a variety of product types such as medicines/drugs, biologics, peptides, advanced therapies, and vaccines.

How can the BlueReg Scientific Writing team help you write the scientific and technical documents required during drug development?

The BlueReg Scientific/Medical Writing team has a strong understanding in drug/medicine development, together with a substantial practical and technical experience to support your team.

Our Scientific/Medical Writing experts team up and work closely with all cross-functional representatives to ensure the development strategy is fully and accurately captured into high-quality scientific and technical documents.

Our scientific/medical writers have demonstrable scientific and technical writing expertise/experience and BlueReg offers scientific writing services to support you with the following documents.

Documents supporting Regulatory Procedures:

Orphan Drug Designation (ODD) Application and its Annual reports.
Paediatric Investigation/Study Plan (PIP/PSP) and its Amendments.
Scientific Advice/Protocol Assistance Briefing Package (National, EMA, FDA).
FDA: Fast track designation, Breakthrough Therapy designation and accelerated approval pathway.
EMA: Micro, small and medium-sized enterprise (SME) status application.

CMC:

Active Substance Master File (ASMF) and Drug Master File (DMF).
Certificate of Suitability to the European Pharmacopeia (CEP).

Non-Clinical Trials:

Non-Clinical Study Reports.

Clinical Trials:

Protocol and Informed consent form (ICF).
Investigator’s Brochure (IB).
Clinical Study Report (CSR) and associated activities, such as:
- CSR lay summaries,
- Registry posting
Investigational Medicinal Product Dossier (IMPD) and its amendments.
Investigational New Drug (IND) application and its annual reports.
Development Safety Update Report (DSUR).

Internal Company Documents:

Advisory Board meeting minutes.
Target Product Profile (TPP).

How can the BlueReg Scientific Writing team help you write a CTD dossier for registration?

The BlueReg Scientific/Medical Writing team has a thorough and technical knowledge and experience of all Common Technical Dossier (CTD) modules supporting marketing authorisation applications globally or in specific region (e.g., EMA and FDA).

Our Our Scientific and Medical Writing experts regularly work in close collaboration with regulatory submission teams to develop the CTD modules in line with your registration strategy.

Our scientific/medical writers have demonstrable CTD dossier writing expertise/experience and BlueReg offers scientific writing services to support you with the following documents.

CTD Dossier

All modules for the CTD, including:

Module 1

Legal basis justification for specific application types (e.g. bibliographical applications, exceptional circumstances, and conditional approval [EMA], priority review [FDA])
Environmental Risk Assessment (ERA)
Risk Management Plan (RMP)

Module 2

Quality Overall Summary
Non-Clinical and Clinical Overviews and Summaries

Module 3

All CMC sections

Modules 4 and 5

Non-clinical and clinical study reports, Integrated Summary of Safety/Efficacy (ISS/ISE), tabular listings:
- Redaction of documents in line with EMA Policy 70

Response to questions from Regulatory Authorities.

CMC

Baseline electronic CTD (eCTD) dossier preparation for international registration (CMC-related).
Core dossier preparation for geographical roll-out.
API site registration dossier.

Internal Company Documents

Company Core Data Sheet (CCDS).

How can the BlueReg Scientific Writing team help you maintain the CTD dossier during lifecycle management?

The BlueReg Scientific/Medical Writing team has a substantial scientific, technical, and regulatory knowledge in maintaining CTD dossier and addressing post-approval measures.

Our Scientific and Medical Writing experts are key members of lifecycle management teams to support you with amendments of relevant CTD modules in line with the post-approval requirements

Our scientific/medical writers have demonstrable scientific, technical and CTD writing skills and BlueReg offers scientific writing services to support you with the writing or reviewing of the following documents.

CTD Dossier

CTD module updates as required per the post-approval activities.
Baseline eCTD dossier preparation for international maintenance (CMC-related).

Clinical Trials

Protocols and Clinical Study Reports (e.g. for a Post-Authorisation Safety Study [PASS] or Post-Authorisation Efficacy Study [PAES]).

Safety Reporting

Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Evaluation Reports (PBRERs).

Internal Company Documents

Updates to the CCDS.

Some examples of our latest engagements

Development:

PIPs, ODDs.
Scientific Advice/Protocol Assistance Briefing Packages for EMA and national consultations as well as for pre-IND meetings (CMC, non-clinical and clinical sections).
Protocol synopses and IBs.
INDs and IMPDs (CMC sections).

Registration:

Full CTD modules for regulatory submission in the EU and the US.
CTD modules and other documents for an EMA pre-submission meeting (RMP, and CMC, non-clinical, clinical sections).
Legal basis justifications (e.g. for well-established use, generic and hybrid application).
Baseline eCTD dossier.

Lifecycle Management:

CCDS updates.
Baseline eCTD dossier.

Associated services

CMC Regulatory support

Our CMC Regulatory support services include everything from regulatory strategy and preparation of meetings with health authorities, assessment and preparation of regulatory documents, responses to agency questions, maintenance of products on market, regulatory compliance strategy worldwide and geographical roll out.

Associated services

Preparation, writing and redaction of clinical study reports

BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.

Marketing Authorisation Holder Transfer for 60 MAs

Our client a global pharmaceutical and biotechnology company specialising in the research, development and marketing of medicines and vaccines for...

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