Pharmaceutical Regulatory & Project Consulting

We provide expert guidance across fundraising, regulatory affairs, plant audits, and project execution. Our team helps pharmaceutical innovators avoid costly missteps and achieve milestones with clarity, compliance, and confidence.

Fundraising & Grants

Identify opportunities and craft winning applications to secure non-dilutive funding.

What we deliver

Grant landscape & eligibility mapping: IMDA, EDB, EnterpriseSG, NRF, A*STAR, H2020/IMI, NIH.
Proposal development: problem/solution framing, aims, methodology, clinical/CMC plans, impact & commercialization.
Budget & compliance: allowable cost checks, staff time models, equipment/overhead justification.
Evidence pack: preliminary data, letters of support, partner MOUs, market sizing & IP status.
Submission QA: criteria cross-walk, reviewer checklist, formatting, online portal submission.
Post-award setup: milestones, reporting cadence, risk register, audit-ready finance tracking.

Typical timeline: 2–4 weeks for scoping & drafts; 1–2 weeks for compile/QA; fast-track available.

Project Mapping (POV/POC)

Translate ideas into execution plans with clear milestones, success metrics, and risk controls.

Scope & planning

POV (proof of value): clinical/economic value hypotheses, endpoints, success criteria.
POC (proof of concept): technical feasibility, assay/analytical design, sample size & acceptance limits.
Workplan & Gantt: activities, owners, dependencies, critical path, stage-gates.
Resourcing: internal capacity vs CDMO/CRO; RACI matrix; procurement lead times.
Risk & mitigations: RAID log, quality gates, change control & deviation handling.
Readout package: methods, results, decision memo for next-stage funding.

Outputs: POV/POC protocol, timeline, budget, KPI dashboard, and decision dossier.

Regulatory Affairs

Right-size your pathway strategy and CMC/CTD documentation for FDA/EMA expectations.

Pathway & documentation

Gap assessment: ICH Q series, stability, impurities (Q3A/B), specs & methods readiness.
CTD authoring/review: Modules 2–5 structure; quality summaries, validation reports, CoAs.
Agency interactions: pre-IND/Scientific Advice prep, question matrices, briefing books, meeting minutes.
Lifecycle: variations/renewals, comparability, post-approval changes, PSUR/ASMF/DMF updates.
Global alignment: FDA/EMA/NMPA/HSA requirements harmonization; eCTD publishing readiness.

Artifacts provided: regulatory strategy, CTD templates, response templates, and submission checklist.

Plant & Quality Audits

Be inspection-ready with GMP audits, CAPA plans, and supplier qualification.

Audit scope

Readiness reviews: data integrity (ALCOA+), batch records, deviations, change control.
Facility & utilities: HVAC, water systems, cleaning validation, environmental monitoring.
Manufacturing controls: OOS/OOT handling, IPCs, line clearance, equipment logs.
QMS: SOPs, training, supplier qualification, complaint/recall procedures.
Supplier/CDMO audits: qualification, quality agreements, ongoing performance KPIs.

Deliverables: risk-ranked findings, CAPA plan with owners/dates, and follow-up verification audit.

Pharma Project Management

Keep scope, cost, and schedule on track with transparent dashboards and PMO rigor.

PMO framework

Planning & governance: WBS, milestones, steering cadence, decision logs.
Tracking: timeline burn-down, earned value, cost/schedule variance, risk heatmaps.
Cross-functional sync: CMC, clinical, regulatory, supply — issues/blocks escalation.
Quality & change: change control board, deviation tracking, audit trail.
Reporting: exec dashboards, sponsor updates, investor-ready progress summaries.

Outcomes: predictable delivery, fewer surprises, and on-time critical path execution.

Tell Us About Your Project

Our team is ready to review your needs and craft a tailored consultation.