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
Medical Devices Consulting
Regulatory Strategy & Due Diligence
FDA Meeting Preparation & Engagement
In Vitro & Companion Diagnostics
Quality Systems & Training
Pharmaceuticals & Biologics 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
- 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
Medical Devices at Every Stage
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
Let us help navigate you through the process
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