Service lines
What we do
Open any line for the full scope. Most engagements draw on two or three at once, run by one named lead so the interfaces are somebody's job.
01 Regulatory Affairs Getting to market — and recovering when things go wrong
Getting to market
- US submissions: IND, NDA, BLA and ANDA; 510(k), De Novo and PMA for devices; combination-product and Request for Designation strategy
- Agency strategy and negotiation: Type B and C meetings, pre-IND and End-of-Phase meetings, Q-Sub and Pre-Sub, EMA scientific advice, national competent authority engagement
- Federally scheduled investigational compounds: registration and scheduling strategy, research and manufacturing licensure, and cross-border authorisations
- Orphan drug, Fast Track, Breakthrough and expedited-pathway designation requests
- EU MDR and IVDR technical documentation; filings across Japan, China, Canada, Australia, India, Brazil, the UK and the Gulf states
- Standards interpretation and gap analysis: ICH, ISO, IEC, USP / EP / JP; promotional, labelling and advertising review
When things go wrong
- Clinical hold responses, Refuse-to-File recovery and Complete Response Letter remediation
- Form 483 responses, Warning Letters, and Consent Decree remediation and exit
- Recalls, field safety corrective actions and market-withdrawal strategy
- FDA import alerts, held shipments and re-entry strategy
- Notified body nonconformity closure and certificate recovery
- Regulatory intelligence: tracking draft guidance and standards before they bind you
02 CMC, Manufacturing & Validation Where regulatory strategy meets a purchase order
Chemistry, manufacturing and controls
- Phase-appropriate CMC development plans and Module 3 authoring
- Drug substance and drug product process development, scale-up and technology transfer
- Analytical method development, validation and transfer; specification setting and justification
- Stability programme design, shelf-life justification and packaging validation
- Formulation, container-closure, extractables and leachables, and in-use stability
- Modelling support including PBPK, and biocompatibility and toxicology strategy
Supply chain and qualification
- CDMO, CMO and testing-laboratory identification, RFP management, qualification and audit
- Supplier qualification, control, change notification and approved-supplier list management
- Facility, utility and equipment qualification — IQ, OQ, PQ; FAT and SAT
- Process validation and continued process verification; cleaning and sterilisation validation
- Computerised system validation and risk-based software assurance
- SOP and batch record development; operator training and qualification
03 Clinical Development & Operations Run to the strictest jurisdiction you touch
Design and delivery
- Clinical development strategy, trial design and endpoint selection
- Protocol, statistical analysis plan and clinical study report authoring
- CRO and Phase 1 unit identification, RFP management and qualification
- Site selection, contract negotiation, IRB and ethics committee submissions
- Risk-based oversight, initiation and close-out visits; query management
- Decentralised and hybrid trial design; IND and IDE support
Data, evidence and medical affairs
- Biometrics and clinical data management; statistical planning and analysis oversight
- Data governance and integrity under ICH E6(R3)
- Investigator's Brochure authoring and maintenance
- Real-world evidence strategy and registries; publication planning
- Investigator and KOL relations; DMC and adjudication committee management
- Literature review, clinical evaluation reports, and reimbursement / HEOR strategy
04 Pharmacovigilance & Drug Safety Inspection-ready from the first case
Building the function
- Safety Management Plans, PV standard operating procedures and work instructions
- Case repository design — validated safety database or controlled manual system, sized to your stage and structured to ICH E2B(R3) data elements
- Reference safety information and expectedness frameworks; adverse events of special interest definitions and handling rules
- Pharmacovigilance agreements and safety data-flow definitions with CROs, sites and EDC providers
- Site and CRO training; documented submission dry run before first dose
- Migration planning and costed change options as volumes grow
Running it
- Day-to-day case management: intake, triage, entry, independent second-person quality control, MedDRA and WHODrug coding, narrative authoring, follow-up to closure
- Expedited reporting: 7- and 15-day IND safety reports, investigator notifications and IRB reporting support
- Development Safety Update Reports, line listings and summary tabulations
- Quarterly reconciliation against EDC adverse event data; dictionary re-coding at each release
- Structured medical review and signal review; DSMB and safety review committee support
- Monthly metrics, quality-control records and inspection-ready control documentation
05 Quality Systems & Compliance Built to survive an inspection, not just an audit
Build and remediate
- Phase-appropriate QMS design and gap analysis for GxP environments
- Document control, change control and training systems that a small team can actually operate
- CAPA, deviation, complaint handling and nonconformance systems
- Risk management to ISO 14971, integrated with design control rather than bolted on
- Electronic QMS selection, deployment, integration and validation; 21 CFR Part 11 controls
- Data integrity assessment and remediation
Audit and prepare
- Practice FDA, EMA and notified body inspections run against the current compliance programme
- GCP, GLP and GMP vendor and site audits, domestic and international
- Supplier, distributor, partner and transactional due-diligence audits
- Certified auditors and former regulators on staff
- MDSAP readiness and audit support
- Inspection hosting: front room and back room management, and response drafting
06 Strategy, Diligence & Program Management Timelines a board, a bank and a regulator can each read
Strategy
- Market, scientific, intellectual property and regulatory intelligence
- Pathway and portfolio selection, including the case for not pursuing a programme
- Build, buy, licence or partner analysis
- Reimbursement, coding and pricing strategy
- Growth, transition and exit planning
- Diligence support for financing rounds and M&A, on either side of the table
Program management
- Integrated plans, budgets and critical-path timelines
- Resource and cost management across internal and vendor teams
- Metrics, dashboards and board-level reporting
- Stakeholder presentations for investors, investigators, agencies and partners
- Training design and delivery
- Program recovery when a timeline has already slipped
Sectors
Where we work
Weighted toward drugs and biologics, with a long device and diagnostics history behind it — which is why combination products and borderline classifications tend to land here.
Small molecules
Biologics
Psychedelic therapeutics
CNS & psychiatry
Oncology
Combination products
Medical devices, all classes
Diagnostics & IVDs
Software, SaMD & AI
CLIA & laboratory services