 |
 |
| |
|
Our project teams are made up of world-class experts with decades of experience and international recognition in their areas of expertise.
NDA Partners is different from conventional consulting firms. Our approach is to provide an experienced team consisting of experts in clinical development, clinical pharmacology, regulatory strategy, clinical practice, pre-clinical development, pharmacokinetics, CMC, and program management to work with our clients rather than provide individual practitioners to consult independently in their area of expertise. This team, with its broad experience, allows us to analyze issues quickly, comprehensively, and holistically within the context of the client's overall product goals and strategies and formulate high-impact recommendations that are concise, actionable and based upon good science as well as good business.
NDA Partners Functional Expertise
- Drugs, biologics and devices
- Formulation and product development
- Safety assessment
- Clinical pharmacology
- Pharmacokinetics and drug metabolism
- Pharmacometrics
- Clinical development
- Non-clinical development
- Biostatistics
- Devices and diagnostics
- Regulatory strategy and submissions
- Pharmacogenetics
- Project and program management
NDA Partners brings decades of experience of medical device development to clients who need a strategic regulatory path and assistance with:
- 510k strategy and submissions
- Design of clinical studies
- IDE submissions
- PMA submissions
- Request for Designation (RFD) to determine appropriate regulatory jurisdiction
- Request to determine appropriate product classification (513(g))
- FDA Communications (meetings, conference calls, regulatory filings)
- Non-clinical testing needs including biocompatibility and performance testing
- Application of standards in the regulatory process
- Validation of endpoints and Patient Reported Outcomes (PRO)
- Application of Quality System Regulations
- Post-market surveillance
NDA Partners Product Experience
Cancer
- Novantrone (breast cancer)
- Leucovorin Calcium (cancer)
Infection/HIV
- Ceftin (antibiotic)
- Pipracil (antibiotic)
- Videx (AIDS)
- HIVID (AIDS)
- Lamivudine (Epivir)
- Amprenevir (Agenerase)
- Ceftazidime (Fortaz)
- Zidovudine and lamivudine (Combivir)
- Wound management clinical trials
Gastrointestinal
- Ranitidine (Zantac) (ulcers)
- Ondansetron (Zofran) (nausea)
Inflammation
- Celecoxib (COX-2 arthritis and pain)
Pulmonary
- Salmeterol (Serevent)
- Fluticasone (Flovent)
- Salmeterol and Fluticasone (Advair)
- Fluticasone (Flovent)
- Albuterol (Ventolin)
CNS and Pain
- Cognex (Alzheimer's)
- Sumatriptan (Imitrex) (migraine)
- Naratriptan (Amerge) (migraine)
- Toradol (pain)
- Concerta (ADHD)
Cardiovascular
- Ziac (Antihypertensive)
- Zebeta (Antihypertensive)
Dependence
- LAAM (opiate dependence)
- Subutex (opiate dependence)
- Suboxone (opiate dependence)
Devices
- Orthopedics
- Bioengineered tissue-based products
- Cardiovascular devices
- Neurological devices
- Implants
- Combination Products
- In Vitro Diagnostics
|
|
|
|
|
