PHARMACEUTICAL
Pharma services (generic/new drugs/biologics)
- Authority communications
- Submission
- Licensing UE (Centralized also)
- Grandfathering & UK baseline (due to Brexit)
- Variations
- Life cycle
- Audits
Pharma Dossier Preparations, Submission, and Approval
- Dossier writing (CMC & medical writing) for CTD, aCTD, eCTD, and Special formats
- Consulting for M1 writing
- Updates
- Consulting for New markets requirements
- Global Regulatory Strategy
CMC
- Batch disposition and deviation resolution
- Biopharma CMC
- Validations strategies (Product & Cleaning)
Quality
- Classification of Changes
- PSUR (Periodic Safety Update Reports)/ PBRER (Periodic Benefit-Risk Evaluation Report)
- SOP´s
- Quality manuals
NUTRACEUTICALS
- General Consulting Services
- FDA Compliance
- Stability Data
- cGMP Compliance
- Supplier Qualification
- Advice on Dietary Supplement Clinical Trials
- Adverse Event Reporting
- Dietary Supplement Label Review
- Audits
- Specification Development
- Government Agency Representation (in the US and in the EU)
- Regulatory, Safety, Risk, and Feasibility Assessments
- GRAS Notification
- NDI Notification
- EFSA Notification
MEDICAL DEVICE
Regulatory
- FDA 510k submissions / Denovo submissions
- FDA Negotiations
- Premarket Notifications (510(k)) – Including Notes to File (FDA)
- Investigational Device Exemptions (IDE) and Supplements (FDA)
- Premarket Approval Applications (PMA) and Supplements (FDA)
- Labeling/Promotional Materials Review
- FDA Registration and Listing
- SBD
- EU (MDD and MDR)
- Competent Authority Negotiations
- MHRA UKCA
- MHRA UKRP
- Clinical Evaluation Reports
- Technical Files – Class I, IIa, IIb, and III
- Design Dossiers – Active Implantables
- Canada
- Premarket Submissions
Quality
- ISO 13485 Quality System Design/Compliance/Auditing
- FDA QSR and Human Tissue GMP Design/Compliance/Auditing
- Managed several Level I and Level II QSR audits (in US and Japan) and Human Tissue
- FDA Negotiations/Responses to 483’s, Warning Letters, and Recalls
- Managed Recall/Complaint Handling/Vigilance Reporting/MDR Process
- Internal Audits
Clinical
- Overall Clinical Study Management – Phase II, III, and Post Marketing Surveillance/PMCF
- Protocol design/development
- Case Report Form design/development
- Insurance Reimbursement
- Bioresearch Monitoring
- Managed FDA Sponsor Bioresearch Monitoring Visits
- Assisted Clinical Study sites with FDA Bioresearch Monitoring Visits