Creative Biolabs ensures precise, compliant medical writing and translation services.
Medical Writing ServicesTranslation ServicesRelated Services
Regulatory medical writing and translation have been essential to pharmaceutical and biotechnological product development throughout the product life cycle. Whether it be the documenting, presenting and submission of clinical and non-clinical data to healthcare authorities all over the world, ensuring compliance to complex frameworks created and used by the FDA, EMA, APAC regulatory agencies and more, which helps to reduce product approval and submission lead times.
Empowered by a qualified team of experienced and skilled medical writing professionals with both research and pharmaceutical backgrounds, Creative Biolabs provides a full spectrum of regulatory medical writing services, including developing quality documents, performing peer review and coordinating client review, conducting quality checks and accomplishing the program management of a wide range of regulatory writing activities in both electronic Common Technical Document (eCTD) and CTD modules.
Creative Biolabs delivers comprehensive medical writing services, addressing each phase of the regulatory and clinical process. Our expertise spans the creation, review, and management of essential documents for clinical trials, market approval applications, and post-market compliance. These services ensure all submissions align with health authority requirements while maintaining scientific clarity and regulatory accuracy.
Service
Document Type
Advantages
Regulatory Alignment
Clinical Overviews
eCTD Module 2.5
- Comprehensive synthesis of clinical findings
- Robust cross-referencing across studies
- Supports global regulatory submissions
FDA, EMA, APAC regions
Clinical Summaries
eCTD Module 2.7
- Detailed presentation of pharmacological, safety, and efficacy results
- Ensures data consistency across trials
FDA, EMA, MHRA
Clinical Study Reports (CSR)
eCTD Module 5
- Full statistical and safety data analysis
- Clear, concise presentation for regulatory evaluation
Global health authorities
Regulatory Strategy Support
Gap Analysis and Biowaiver
- Identification of gaps to avoid submission delays
- Expert biowaiver document preparation
FDA, EMA, APAC
Health Authority Interaction
Briefing Documents, Responses
- Strategic preparation for regulatory meetings
- Effective responses to regulatory queries
FDA, EMA, MHRA, APAC
Technical Review
Dossiers and Validation Protocols
- Independent quality reviews
- Ensures submission readiness and compliance
EU, US, China, India
Our medical writing team has demonstrated proficiency in delivering superior regulatory medical and scientific writing services for pharmaceutical and biotechnology companies worldwide in accordance with strict timelines and high-quality parameters. We also ensure that the writing is in line with the corresponding studies.
Translation Services
Creative Biolabs offers precise and culturally adapted translation services to meet the multilingual demands of regulatory submissions and global product registrations. Our translation services cover a wide range of critical documents, ensuring accuracy, consistency, and compliance across markets. With expertise in regulatory affairs and multilingual proficiency, we streamline documentation for international approvals.
Service
Document Type
Advantages
Regulatory Alignment
CTD Modules Translation
Modules 1-5
- Accurate translation across clinical, technical, and non-clinical modules
- Facilitates multinational submissions
EMA, FDA, MHRA
Packaging and Labeling Compliance
Packaging, Labels
- Ensures local regulatory compliance
- Aligns with regional linguistic standards
EU, FDA, APAC regions
Summary of Product Characteristics
SmPC, PIL
- Clear, concise translations tailored for healthcare professionals and patients
- Supports regional marketing requirements
- Enhances patient comprehension
- Aligns with diverse regional healthcare policies
EU, FDA, APAC
Multilingual Support
50+ Languages
- AI-enhanced translation tools ensure efficiency
- Coverage across 50+ languages for global reach
Global markets
Creative Biolabs is an experienced regulatory writing and translation services provider for writing, independent quality review and technical review of dossiers, identifying gaps for already prepared or compiled dossiers, and regulatory translation. Our regulatory medical writing and translation team is committed to catering to specific requirements of various regional Health Authorities (HAs) of USA, EU, and some APAC regions including China, India and Philippines. Any regulatory medical writing or translation requirements, please feel free to contact us for more information and a detailed quote.
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