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

• Represent clients in interactions with FDA
• Assist with preparations for FDA and Advisory meetings
• Provide clients with an ‘FDA style’ review of submissions
• Advise on regulatory options and potential pathways

FDA Submissions

• Author, review and publish original IND, NDA, BLA, MF, and OD applications, amendments and supplements
• Create or assist with the refinement of regulatory strategy

Nonclinical Development

• Nonclinical pharmacology and toxicology support for drugs and biologics
• Early-stage development planning assistance
• GLP consulting, oversight and compliance
• Nonclinical program review and strategic support for FDA submissions
• Safety assessments for biologics, small molecules, devices, biosimilars and combination products
• Review of study protocols and reports for scientific merit and regulatory compliance
• Nonclinical CRO selection and oversight support

Clinical Development

• Clinical regulatory expertise for products in all stages of clinical development
• Strategy and guidance for IND, NDA and BLA efforts, including FDA meeting requests, briefing packages, preparation, and attendance, and preparation of the clinical portions of applications
• Expertise in the development of biosimilar products
• Support for ANDA and 505(b)(2) applications
• Clinical gap analyses, product development plans, and due diligence assessments
• Authoring of iPSPs, fast track/breakthrough therapy requests and orphan drug designation requests
• Phase 1-4 clinical protocol development
• “FDA style” clinical data review
• Clinical trial support for drugs and biologics
• Clinical trial planning and oversight of studies conducted by CROs or individual investigators, including CRO selection and contract negotiation, clinical operation tasks and timelines, investigator/site selection, site training, preparation/review of study documents, medical monitoring and DSMB organization

CMC Development

• Regulatory, Quality Assurance & Compliance services for drugs and biologics
• Quality-based manufacturing and analytical method development
• Validation
• Formulation development
• Assessment and evaluation of stability data and requirements
• Preparation and review of regulatory submissions
• Risk-based strategies for product development
• Oversight of contract services
• Design, implementation and upgrade of manufacturing systems covering a range of products including small molecules, biologics and biosimilars

Audits

• GMP and GLP facility and GCP compliance
• Gap assessments, PAI readiness
• Commercial readiness
• Data audits (integrity and validation)
• Computer systems validation and Part 11 compliance

Regulatory Strategy & Due Diligence

• 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 Meeting Preparation & Engagement

• Represent clients in interactions with FDA
• Assist clients in preparing for FDA meetings and FDA Advisory Panel meetings

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