Consulting Services

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
Nonclinical Development
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

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 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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