SERVICES
WE PROVIDE CONSULTING SERVICES FOCUSED ON THE NEEDS OF YOUR COMPANY
REGULATORY AFFAIRS & CLINICAL RESEARCH
DRUGS, BIOLOGICS &
MEDICAL DEVICES
TANGIBLE QUALITY GOALS
From submissions to post-market surveillance, our experienced consultants can guide your regulatory strategy for various international markets and ensure you are in compliance every step of the way. We can also help you organize and develop your clinical research program
Our team of experts have experience working with a variety of products including drugs, all classifications of medical devices, biologics and nutritional supplements.
Quality is embedded in regulations. We can help ensure that your products consistently meet all applicable requirements and specifications based on tangible quality goals
REGULATORY FILINGS
Regulatory filings are the cornerstone of marketing your product, we can provide guidance with a variety of international filings
IND/NDA
510(k)
CE Mark
Product Registration
AUDITS
Audits can be stressful, we can prepare you for them and ensure you demonstrate full regulatory compliance for
MDSAP
FDA
ANVISA
Notified Body
TRAINING
Training ensures employees have the required skills to perform their duties and follow the regulations. We can conduct and tailor training in
CAPA
Qualification and Validation
CGMP
Regulatory Compliance
MANUFACTURING
We understand the importance of quality. Our experienced consultants can help you establish a robust quality program including
Quality Assurance
Quality Control
Product Optimization
Validation & Verification
Quality Management