Our Consulting Areas of Expertise
We provide Practical, Actionable, and Strategic Solutions in an Integrated, Thorough (PASS-IT) manner to the global healthcare industry.
Our services include, but are not limited to, consulting, research direction/guidance, training, and coaching with vision, awareness, and emotional intelligence (EQ) in the following areas:
Our Specialized Expertise
Global and FDA regulatory and quality consulting, regulatory compliance, FDA management consulting, medical devices, in vitro diagnostics (IVDs), laboratory developed tests (LDTs), premarket notification (PMN or FDA 510(k)), premarket approval (PMA), quality system regulations (QSR), quality systems, medical device reporting (MDR), corrective and preventive action (CAPA), ISO 13485, ISO 14971, EU medical device directive (MDD), active implantable medical device directive (AIMDD), in vitro diagnostic medical device directive (IVD(M)D), CE mark, biologics, biosimilars, food, drugs (human and animals), cosmetics, combination products, dietary supplements, eCTD, FDA (BIMO) inspection, 483s, FDA warning letters, consent decree (permanent injunction), clinical trials, clinical evaluation, risk management, pharmacovigilance, pharmacy compounding, FDA registration and listing, electronic submission to FDA, structured product labeling (SPL), labeling, research and proposal, etc.
Our Expertise Includes, But Is Not Limited to:
- Research and Product Development
- Design and Development Plan/Planning
- Global Due Diligence for Drugs, Biologics, Biosimilars and Medical Devices including In Vitro Diagnostics
- Patents (Licensed to Practice in Patent Cases before the USPTO)
- Business Consulting with 360 Degree View
- Mapping Regulatory Issues/Pathways
- Regulatory Documentation/Submission/Clearance/Approval/Registration
- Post-Marketing Requirements
- FDA Advisory Committee Meeting Discussion
- Regulatory Issues for Drugs, Biologics, and Medical Devices
- Registration and Listing with the FDA
- Adverse Event Reporting/MedWatch using FDA’s Electronic Submissions Gateway (ESG)
- FDA Enforcement Matters (Product Recalls, Import Alerts, MDRs, FDA Inspection, 483s, Warning Letters, etc.)
- Staff training seminars
Our Expertise in Regulatory Affairs
- US agent services to our global clients
- Assess, draft and submit regulatory applications or submissions for food, dietary supplements, pre-IDE, IDE, 510(k), 513(g), PMA, NDA, ANDA, RFD, Petition, CE marking, etc.
- Guidance on how to write and format a pre-IDE, IDE, 510(k), PMA, NDA, ANDA, RFD, Petition, or CE marking in a succinct and comprehensive manner.
- Draft and respond to 483s and FDA warning letters to effectively close out the compliance issues.
- Represent you before regulatory agencies (e.g., US FDA).
- Communicate (liaison) with global regulatory agencies.
- Guidance on labeling and advertising (prescription and non-prescription (OTC) drugs, medical devices including IVDs, dietary supplements, and prescription food).
- Guidance on reimbursement, registration and listing.
- Implementing regulatory requirements
Our Expertise in Quality and Clinical Affairs
- Organizational assessment for statutory and regulatory compliance to the FD&C Act and FDA regulations.
- Training on how to achieve and maintain compliance to FDA regulations for medical devices and drugs.
- Help to establish quality system management (21 CFR Part 820), ISO 9001 and ISO 13485.
- Help to developing validation protocols for methods and processes.
- Help to establish Good Laboratory Practices (GLP).
- Help to establish Good Clinical Practices (GCP).
- FDA mock auditing for compliance to:
- 21 CFR Parts 210-211
- 21 CFR Part 820 (QSRs)
- GCP and pharmacovigilance (PV)
- Auditing for compliance to:Help to prepare for FDA (BIMO) inspection.
- ISO 13485
- ISO 9001
- Draft clinical protocols.
- Help to write SOPs.
Our Expertise in Global, FDA Regulatory Compliance
- Help to implement the following:
- an adverse event reporting system in US, EU and Canada
- ISO 13485 compliant with EU and Health Canada.
- ISO 9001, and ISO 14971
- AIMDD, MDD and IVDD
- Many other directives and standards
- Designing nonclinical studies under GLP regulations
- Implementing GCP practices
- cGMPs for drugs including compounded drugs, medical devices/IVDs and dietary supplements
- FDA Inspection preparation and management
Our Expertise in FDA Advisory Committee Meeting
- Prepare your firm’s slide presentation for use before the FDA Advisory Committee Meeting.
- Provide your firm’s winning presentation skills and strategy.
Our Expertise in Litigation Support: Defective Medical Product Liability Lawsuit
- Write our expert opinions based on our own serious, independent research
- Support defective medical product liability lawsuit and litigation by sharing our critical scientific and technical skills and know-hows.
- Help you build your case using our exceptional expertise in many medical products.
Last Updated: 2016-10-22