Consulting Services
We offer full-service regulatory and product development consulting services for biologics, pharmaceuticals and medical devices. Our extensive team of Nonclinical, Clinical, CMC and Medical Device Consultants provide world-class service to clients large and small.
Pharmaceuticals & Biologics Consulting
Regulatory Strategy & Due Diligence
FDA Meeting Preparation & Engagement
FDA Submissions
Clinical Development
CMC Development
Audits
Medical Devices Consulting
REGULATORY STRATEGY & DUE DILIGENCE
FDA MEETING PREPARATION & ENGAGEMENT
FDA SUBMISSIONS
COMBINATION PRODUCTS
IN VITRO & COMPANION DIAGNOSTICS
QUALITY SYSTEMS & TRAINING
Medical Devices at Every Stage
Regulatory Strategy & Due Diligence
- Evaluate and provide guidance on all aspects of regulatory strategy for product development
- Support clients developing biologics, small molecules, devices, biosimilars and combination products
- Advise on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions
- Conduct due diligence assessments
FDA Meeting Preparation & Engagement
- Provide short and long term regulatory strategy for medical devices, IVDs, and combination products
- Serve as expert witnesses for litigation matters related to medical device regulation and technologies
- Conduct due diligence assessments
FDA Submissions
- Prepare or assist in the preparation of regulatory submissions for medical devices, including 510(k)s, PMAs, IDEs, de novos, Pre-Submissions, HDEs, 513gs and RFDs
- Assist clients with development of bench, animal and clinical testing protocols and interpreting results
- Provide clients with a comprehensive "FDA style" review of submissions
- Assist with responding to FDA deficiency letters
Combination Products
- Provide insight and guidance on combination product development, including novel drug delivery systems
In Vitro & Companion Diagnostics
- Expert technical guidance on In Vitro Diagnostic product development and regulatory strategy, including companion diagnostics and personalized medicine products
- Analytical and clinical study design and study management
Quality Systems & Training
- Assist with Quality System documentation development including expert technical reviews of software development procedures
- Perform mock audits
- Provide in-house training on FDA regulatory issues and new policy developments
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How we help
Support Services
Medical Writing
Project Management
Electronic Publishing & Submissions
Staff Augmentation
Due Diligence
