Pharmaceutical & investigational drug research consulting.

Who we work with

TheraVite’s consulting practice supports organizations that need experienced pharmacy and regulatory guidance without engaging a full-service Contract Research Organization (CRO). Our typical clients include:

• Sponsor-investigators preparing a first Investigational New Drug (IND) application and managing regulatory obligations they may not have anticipated
• Small and early-stage biotech companies that need targeted regulatory and pharmacy expertise on a project or retainer basis
• Academic researchers and translational science centers planning investigator-initiated trials involving drugs, biologics, or repurposed products
• Clinical trial sites setting up or restructuring an Investigational Drug Service (IDS) capability
• Specialty and community pharmacies considering expansion into clinical research support services
• Sponsors evaluating Connecticut and Northeast sites for pharmacy feasibility as part of protocol planning

Advisory service lines

IND submission & regulatory strategy

Advisory support across the components of a first-in-human or sponsor-investigator IND application: pre-IND meeting preparation, Chemistry, Manufacturing, and Controls (CMC) documentation review, investigator’s brochure input, protocol pharmacy sections, and coordination with the sponsor’s regulatory affairs team. We help clients identify the correct regulatory pathway (traditional IND, expanded access, emergency IND, or exemption), assemble pre-IND meeting packages, and understand ongoing IND maintenance obligations including safety reporting and annual reports.

Investigational Drug Services (IDS) setup & SOPs

For clinical sites and hospital pharmacies establishing or expanding investigational drug capabilities, we develop the operating framework: pharmacy manuals, standard operating procedures, protocol-specific dispensing instructions, blinding and randomization workflows, temperature monitoring and cold-chain SOPs, drug accountability recordkeeping systems, and audit-readiness documentation aligned to ICH E6(R3) Good Clinical Practice.

Protocol pharmacy manual development

For sponsors and CROs, we author the pharmacy manual and protocol pharmacy sections that govern how sites receive, store, prepare, dispense, and reconcile investigational product. Manuals include storage requirements, stability data summaries, dose preparation instructions, compatibility information, disposal procedures, and blinded-vs.-open-label handling guidance.

Site pharmacy feasibility assessments

Pharmacy-focused feasibility evaluations for sponsors selecting sites and for sites qualifying themselves for sponsor consideration. Assessments cover pharmacy staffing, storage infrastructure, blinding capability, compounding capacity, chain-of-custody controls, historical audit performance, and protocol-specific pharmacy operations.

GCP & phase-appropriate GMP consulting

Guidance on Good Clinical Practice compliance for pharmacy and clinical operations, and on phase-appropriate Good Manufacturing Practice expectations for investigational product supply. We help clients understand where GCP and GMP intersect for investigational products, prepare for sponsor and FDA audits, and build quality systems that are proportionate to the phase of development rather than overbuilt at Phase 1 or underbuilt at Phase 3.

Placebo & comparator strategy

Advisory on placebo and active-comparator sourcing, matching, and labeling for blinded studies: strategy on when a matched placebo is required, how to identify qualified GMP manufacturers or repackagers, how to align labeling with ICH standards, and how to plan for kit assembly, drug supply, and interactive response technology (IRT) integration. We advise on strategy; we do not manufacture.

Sponsor-investigator regulatory support

Physicians and academic investigators who become IND sponsors take on substantial regulatory obligations that are often not fully appreciated at the outset. We help sponsor-investigators understand and meet those obligations: annual reports, safety reporting (IND safety reports, expedited reporting), protocol amendment submissions, monitoring plans, essential document management, and audit readiness.

Audit readiness & inspection preparation

Mock audits, gap assessments, and inspection-readiness reviews for pharmacy operations, IDS programs, and sponsor-investigator studies. We prepare teams for sponsor monitoring visits, FDA Bioresearch Monitoring (BIMO) inspections, and internal quality reviews. Deliverables include findings summaries, prioritized remediation plans, and follow-up verification.

Educational sessions & team training

Customized training for research pharmacy staff, clinical research coordinators, investigator teams, and quality assurance personnel. Topics include sponsor-investigator responsibilities, pharmacy accountability documentation, blinding and unblinding procedures, temperature excursion management, and GCP essentials for pharmacy operations.

How we engage

Consulting engagements are structured to match the scope and duration of the need:

• Project-based engagements — defined-scope deliverables such as a pharmacy manual, IND section review, or IDS SOP suite
• Retainer arrangements — ongoing advisory access for early-stage sponsors that need regular regulatory and pharmacy input without hiring a full-time role
• Interim & fractional roles — short-term coverage of pharmacy-side responsibilities during team transitions or capability buildouts
• One-time consultations — hourly or half-day advisory sessions on specific regulatory or pharmacy operational questions

What sets our consulting apart

TheraVite’s consulting practice is grounded in operational pharmacy experience, not solely regulatory theory. Our advisory work is informed by day-to-day specialty pharmacy operations, investigational drug handling, and multidisciplinary clinical coordination — the same disciplines the sponsors and sites we advise are trying to build or improve.

We are deliberately positioned to serve organizations that need pharmacy-focused regulatory expertise but are too early, too small, or too specialized to engage a large CRO for advisory work. Our engagement structures reflect that focus: transparent scoping, fixed-fee or clearly bounded hourly work, and deliverables the client can operationalize immediately.

Related pharmacy services

For sponsors and sites conducting studies in Connecticut or the surrounding region, TheraVite’s licensed pharmacy also offers operational Research Pharmacy Services — receipt, storage, dispensing, accountability, and audit-ready documentation of investigational product under sponsor protocols. Consulting engagements and operational research pharmacy services are contracted separately.