Clinical, Quality and

Regulatory Affairs Services

Our Focus Areas:

1. •Medical Devices
   

2. •Healthcare IT
   

3. •Telehealth
   

4. •Diagnostics
   

5. •Pharmaceuticals
   

6. •Biotechnology
   

7. •Emerging and Disruptive Technologies

1. Clinical and Regulatory Assessments
   

2. •Evaluation and planning  of pre-clinical, clinical, and regulatory pathways for specific applications. Includes estimated budgets and timelines.
   

PLANNING

1. •Product research and analysis of regulatory history for similar products.
   

2. •Initial regulatory options and requirements.
   

PRODUCT DEVELOPMENT AND MARKET APPROVALS

1. •Detailed regulatory strategy and requirements.
   

2. •Standards compliance.
   

3. •Design Control documentation and activities.
   

4. •Risk assessment.
   

5. •Scientific and clinical literature reviews.
   

6. •Human factors assessment.
   

7. •Labeling preparation (eg, product inserts, brochures, website and marketing material).
   

8. •Regulatory negotiations, meetings and communications.
   

9. •SOP development.
   

10. •Animal preclinical study planning, protocol preparation, execution and reporting.
    

11. •Biocompatibility and toxicology study planning and management.
    

12. •GMP, GLP, and ISO Auditing.
    

13. •Device submission preparation and negotiation (e.g., PMA, 510k, Technical Files).
    

14. •International submissions and approval management.
    

CLINICAL MANAGEMENT

1. •Preparation of clinical protocols, Investigators Brochure, Informed Consent, and Case Report Forms.
   

2. •FDA, EU and ROW Investigational applications (e.g., IDE, CTX, EU Studies).
   

3. •Principal Investigator relations and management.
   

4. •Data Safety and Monitoring Board management.
   

5. •Statistical planning and management.
   

6. •Clinical study reporting.
   

7. •Clinical site monitoring and GCP auditing.
   

POST MARKET ACTIONS

1. •Product complaint evaluations and Medical Device Reporting (MDR).
   

2. •Product recall preparation and execution.
   

3. •Marketing communications and advertisement reviews.
   

4. •Product regulatory change control.

1. ADDITIONAL
   

2. •Product Research including Analysis of FDA Basis of Approvals
   

3. •Scientific and Clinical Literature Reviews.
   

4. •Marketing Communications and Sales Literature Reviews.

Regulatory Strategy and Planning

1. •Development of Integrated Product Development Plans
   

2. •Product Research and Analysis of Summary Basis of Approvals
   

3. •Drug-Device Combinations
   

Regulatory Submissions

1. •Drug applications (IND, CTX, NDA/BLA preparation)
   

2. •Master files (drug and device), briefing documents, annual reports
   

3. •IND Lifecycle management Paper and e-CTD format
   

4. •Specialized submissions
   

5. •Special Protocol Assessment, Fast Track Designation Request, Target Product Profile, Written Request (pediatric development), biowaiver request, briefing documents, Request for Designation (combination products), Request for Certificate of Pharmaceutical Product (US)
   

Health Authority Interactions

1. •Meetings with FDA (Type A, B, C), EU Scientific Advice Meetings,
   

2. •Expert guidance on issue identification, briefing document preparation
   

3. 
   

Regulatory Oversight For Development Programs

1. •Oversight for Global Clinical Programs (Phase 1, 2, 3)
   

2. •Risk management Change Management Programs
   

3. •Regulatory Inspections
   

4. •GXP Compliance
   

Nonclinical Development

1. •Preclinical/Toxicology Study Planning and Execution and Reporting
   

2. 
   

Clinical Development

1. •Human Study Investigational and Post-market Planning, Execution, and Reporting.
   

2. •Clinical management and Principal Investigator and Clinical Site Relations; including IRB, Co-investigators, Study Coordinator, KOLs, Core Labs, CECs, SABs.
   

3. •Human Clinical Development Strategy
   

Due Diligence and Gap Analysis