Biotech Research Group

Consulting services provided by Biotech Research Group to assist pharmaceutical companies with New Drug Application (NDA) pre-submission activities including proprietary submission and review, establishment registration and labeler code assignment, and pre-submission meeting requests.

Regulatory consulting service to support and expedite FDA Fast Track designation and submissions for drugs addressing unmet medical needs.

Consulting service for Investigational New Drug applications to assist clients with FDA approval processes.

Consulting services guiding clients through biologics product development from conception to commercialization, including BLA applications and compliance with FDA regulations.

Quality assurance services including ISO clean room operation & maintenance, audits, SOP implementation & training, hazard control plans, environmental monitoring, FDA adverse reporting events, deviations and corrective actions.

Independent quality control inspections for clinical trial sites, vendor audits, and implementation/review of validation protocols and SOP management.

Auditing support services including GAP assessments, internal audits, supplier audits, ASQ audits, due diligence, mock FDA inspections, and MDSAP audits by Biotech Research Group.

Consulting services by Biotech Research Group scientists to provide literature review work products tailored for regulatory submissions, including polished sections for submissions or bibliographies for client research.

A service provided by Biotech Research Group acting as the FDA U.S. Agent for foreign establishments importing or offering products for import into the United States, serving as the primary point of contact between FDA and the firm.

Consulting services guiding the design and implementation of compliant cGCP QMS and clinical trial protocol execution to ensure data integrity and regulatory compliance.

Consulting service providing guidance on Periodic Adverse Drug Experience Report (PADER) submission to FDA, helping companies and marketing authorization holders comply with regulatory safety reporting requirements.

Consulting service to guide companies through all phases of clinical trials from Phase I to Phase IV with tailored project plans.

Professional writing services for package inserts, clinical synopsis, editorials, product literature, research papers, patient information sheets, questionnaires, clinical study reports, safety update reports, and adverse reaction reports.

Service to assist clients with FDA establishment registration and annual renewal processes.