DynaMD pharmaceutical and medical device regulatory consulting services will help you successfully navigate regulatory audits and/or respond to actions to finalize a resolution as quickly as possible. Our expertise includes FDA regulations, regulatory affairs, clinical trials, product launch, drug labeling, medical device strategic planning, due diligence, pre-market submissions, registrations, import/export requirements, reporting regulatory coordination, and regulatory review.
Services:
Pharmaceuticals
- Biologics
- Biosimilars
- Generics
- Personalized Medicine
- Orphan Drugs
- Over the Counter (OTC)
Medical Devices
- Medical Device Meeting Services
- Medical Device Submissions
Drugs & Biotech
- Regulatory Strategy Consulting
- FDA Meetings
- FDA Submissions
- Nonclinical Drug Development
- Regulatory Due Diligence
- ANDA Submission Consultant
- Quality & Compliance
Pharmaceutical Regulatory Areas:
- Oncology
- Hematology
- Gastroenterology
- Rheumatology
- Cardiology
- Endocrinology
- Nephrology
- Neurology
- Dermatology
- Psychiatry
- Allergy/Immunology
- Infectious Disease
- Urology
- Primary Care
Medical Device Areas:
- Cardiac
- Neurology
- Urology
- Ophthalmology
- Orthopedics
- Obstetrics/Gynecology
- Pediatric
- General