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Pharmaceutical & Biologics

Consulting Services

Dedicated industry experts with decades of hands-on experience with pharmaceuticals and biologics are at your service every step of the way. From regulatory strategy consulting to compliance services, we are here to support you through any pharmaceutical or biologics challenge.

Regulatory Strategy & Due Diligence Services

Our compressive biologics and pharma consulting services offer guidance and validation throughout each product development phase including strategy, compliance support, and 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 Consulting

  • 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 Consulting

  • 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 Services

  • 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 Consulting

  • Formulation development, process, and analytical development
  • Validation
  • Quality-based manufacturing and analytical method development
  • Regulatory support, quality assurance & compliance services for pharmaceutical drugs and biologics
  • 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