Consulting Services

What xCellarate does

  • Provide consulting expertise in three broad areas: Product Development & CMC Manufacturing Support, QA/QC, & Regulatory Affairs.
  • Serve the Pharma/Biotech, NHP, Cosmetics, Food, legal Cannabis industries
  • Provide project management & value-added consulting solutions to complex projects and Technology Transfers
  • Networked or partnered with wide variety of industry professionals, subject matter experts, service providers and vendors
  • Subcontracted GMP auditor with SGS Laboratories and NSF International
  • Conduct consulting work with honesty and integrity
  • Detail-oriented and organized
  • Relationship building/Partnership connector & facilitator

Areas of Specialty

  • Provide mentoring program (ask for details!)
  • Chemistry, Manufacturing and Controls (CMC) for biologics and small molecule
  • Product/Process Development expertise, A-Z manufacturing of Finished Products
  • Preparation of variety of regulatory filings for CMC, Compendial NPN applications, Cosmetic CNF’s, EU Cosmetic Notification
  • NHPD Site Licenses, DEL, Partnered with other consultants for preparation of applications for Cannabis licenses,
  • CMC, GMP, Quality/Compliance Audits for mock purposes, due-diligence for vendor evaluation, vendor qualification
  • GMP Gap analysis and remediation
  • Provide GMP/GPP training
  • Assistance with Contract Negotiations, strategic thinking, developing regulatory strategy
  • Manufacturing technologies for solid, liquid, parenteral dosage forms
  • Aseptic processing

Experience

  • Deep understanding of GMP and application to specific regulated environments
  • GMP auditing, gap analysis, strategy & remediation implementation
  • Technical Writing of a wide variety of document types including but not limited to SOPs, validation protocols/reports, policies, risk assessments
  • QMS design, customization & implementation that is growth-stage appropriate
  • Acting as 3rd party of QA services (including QAP for licensed cannabis companies)
  • Process development for small molecule, biologics, oral and topical dosage forms
  • Experience and partnership for design, construction, C&Q, validation and start-up of cleanroom production facilities; qualification of pharmaceutical equipment
  • Industry manufacturing equipment, spec’ing, sourcing and purchase
  • Risk Management evaluation using FMEA’s, technology due-diligence evaluation