Consulting Services

What xCellarate does

  • Provide consulting expertise in three broad areas:

    1. Product Development & CMC Manufacturing Support,

    2. QA/QC,

    3. 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