Biotech Research Group
Biotech Research Group is a full-service regulatory and product development consulting firm with a global presence, specializing in pharmaceutical consulting, medical devices, healthcare IT, and scientific services. They emphasize quality, global expertise, and cost and time efficiency to help clients navigate complex regulatory landscapes and bring innovative health products to market.
Industries
Nr. of Employees
small (1-50)
Biotech Research Group
3903 Fontainebleau Drive Tampa, FL 33634, United States
Services
End-to-end regulatory support for INDs, NDAs, ANDAs, 505(b)(2), 510(k), PMA/PMN, EUA and related regulatory filings and strategies.
Preparation of briefing packages, regulatory strategy documents, and meeting materials to align development with regulatory expectations.
QA program implementation including ISO cleanroom support, SOP development, audits, environmental monitoring, CAPA and regulatory inspection readiness.
Protocol development, case report form design, site selection, clinical data management and statistical support for clinical programs.
Adverse event reporting processes, preparation of MedWatch/FAERS/AERS reports, periodic safety update reports and safety database support.
Development and execution of design and development plans, design verification and validation, design transfer and device master record preparation.
End-to-end regulatory support for INDs, NDAs, ANDAs, 505(b)(2), 510(k), PMA/PMN, EUA and related regulatory filings and strategies.
Preparation of briefing packages, regulatory strategy documents, and meeting materials to align development with regulatory expectations.
QA program implementation including ISO cleanroom support, SOP development, audits, environmental monitoring, CAPA and regulatory inspection readiness.
Protocol development, case report form design, site selection, clinical data management and statistical support for clinical programs.
Adverse event reporting processes, preparation of MedWatch/FAERS/AERS reports, periodic safety update reports and safety database support.
Development and execution of design and development plans, design verification and validation, design transfer and device master record preparation.
Expertise Areas
- Regulatory compliance and submission strategy
- Clinical trial design and management
- Biologics development and CBER requirements
- Medical device regulatory and design controls
Key Technologies
- eCTD (electronic Common Technical Document)
- Quality by Design (QbD)
- Design controls (verification & validation)
- Human factors engineering
News & Updates
Discussion on FDA's De Novo pathway and medical device regulations.
Overview of FDA's CDRH, EU Medical Device Regulation, and global data standards.
FDA's recent redefinition of the term 'Device' and its implications.
Guidelines and importance of current Good Manufacturing Practices in clinical trials.
Analysis of hand sanitizer regulations and market trends in 2020.
Guidelines and catalog for FDA submissions.
Discussion on FDA's De Novo pathway and medical device regulations.
Overview of FDA's CDRH, EU Medical Device Regulation, and global data standards.
FDA's recent redefinition of the term 'Device' and its implications.
Guidelines and importance of current Good Manufacturing Practices in clinical trials.
Analysis of hand sanitizer regulations and market trends in 2020.
Guidelines and catalog for FDA submissions.