© 2011 Bowman FDA Regulatory Consulting Group, LLC. All Rights Reserved
Pharmaceuticals
Regulatory Strategies
Product development, submission, lifecycle management, recall, labeling, quality, manufacturing and clinical strategies.
Submissions
Product Development Protocols, INDs, ANDAs, and NDAs, amendments and supplements, facility and product registrations, international CTAs, international registration submissions
Compliance
Quality Assurance System Development, GCP system Development, Quality Assurance GMP, GCP, GLP Audits, Regulatory data and filing Audits, Facility Design, Gap Analysis, FDA PAI and semi-annual inspection preparation audits and inspection management, FDA 483 responses, Warning Letter Responses, Consent Decree QA Auditor, Recall Notifications to FDA, Recall Management and GMP/Regulatory/Clinical Trial Training
Due Diligence
Quality/Clinical/Regulatory Assessment Audits – Gap Analysis
Project Management
Product Development Plans for: Pre-Clinical, Manufacturing, Clinical, and Regulatory. Project/Product Management – Cost, Timelines, team management, team communications, submission timelines and requirements
Medical Devices
Regulatory Strategies
Product development, submission, lifecycle management, recall, labeling, quality, manufacturing and clinical strategies.
Submissions
Product and Facility Registrations, Labeling Registrations, IDEs, 510(k)s, and PMAs
Compliance
Quality Systems Development (QSR)s, GCP system Development, Quality Systems: GMP, GCP, GLP Audits, Regulatory data and filing Audits, Facility Evaluations and Design, GAP Analysis, FDA PAI and semi-annual inspection preparation audits and inspection management, FDA 483 responses, Warning Letter Responses, Consent Decree QA Auditor, Recall Notifications to FDA, Recall Management and QSR/Regulatory Training
Due Diligence
Quality/Clinical/Regulatory Assessment Audits
Bio-Technology
Regulatory Strategies
Product development, submission, lifecycle management, recall, labeling, quality, manufacturing and clinical strategies.
Submissions
Product and Facility Registrations, Labeling Registrations, INDs, BLAs or NDAs
Compliance
Quality Assurance Systems Development, GCP system Development, GMP, GCP, GLP Audits, Regulatory data and filing Audits, GAP Analysis, FDA PAI and semi-annual inspection preparation audits and inspection management, FDA 483 responses, Warning Letter Responses, Consent Decree QA Auditor, Recall Notifications to FDA, Recall Management and GMP. Regulatory and Clinical Trial Training
Due Diligence
Quality/Clinical/Regulatory Assessment Audits
Therapeutic Expertise
CNS
Cardiovascular
GI
Anti-infective
Anti-inflammatory
Dermatology
Ophthalmology
Oncology
Endocrinology
Fertility
Pain Management
Product Experience
Injectables
Tablets/Capsule
Powders
Patches
Proteins
Allergenic Products
Large and Small Molecules
Tissue Products
Monoclonal Antibodies
Blood Devices
Surgical Instruments
Ophthalmic Devices
Orthopedic Devices
Dermatology Devices
Cardiovascular Devices
Cardiopulmonary Devices
Infusion and Cardiopulmonary Pumps