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Pharmaceutical & Biologics

Consulting Services

Dedicated experts with decades of hands-on experience with pharmaceuticals and biologics are at your service every step of the way.

Regulatory Strategy & Due Diligence

  • Evaluate and provide guidance on all aspects of regulatory strategy for product development which include protein therapies, cell & gene therapy, and vaccines
  • 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 M&A 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

CMC Development

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

Audits

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