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

DUE DILIGENCE
Helps clients make informed business decisions
Provides professionals to perform comprehensive due diligence reviews
Serves Venture Capitalists, M&A Parties and their Advisors, Industry Venture Groups, Business Development Departments, Alliances and Co-Development Partnerships
REGULATORY STRATEGY
Evaluates and provides guidance on all aspects of regulatory strategy for product development, such as: Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions
EARLY-STAGE DEVELOPMENT
Provides Nonclinical pharmacology and toxicology support for drugs and biologics
Provides Nonclinical program review and strategic support for pre-IND/IND engagements with the FDA
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LATE-STAGE DEVELOPMENT
Provides strategy and guidance for NDA and BLA efforts, including FDA meeting requests, briefing packages, preparation, meeting attendance, and preparation of the clinical and CMC modules
MEDICAL DEVICE SUPPORT
Prepares or assists in the preparation of regulatory submissions for medical devices, including 510(k)s, PMAs, IDEs, de novos, Pre-Submissions, HDEs, 513gs and RFDs
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How we help

Support Services

Medical Writing

Project Management

Electronic Publishing & Submissions

Staff Augmentation

Due Diligence

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