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, Medical Device, 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
Manufacturing technologies for solid, liquid, parenteral dosage forms
Aseptic processing
GMP Gap analysis and remediation
Provide GMP/GPP training
Assistance with Contract Negotiations, strategic thinking, developing regulatory strategy
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
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