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Pharma services: regulatory, clinical, PV, validation and biostatistics

Consultants and managed teams across the development and post-market lifecycle, for sponsors, CROs and device manufacturers.

Vakula Technologies Inc is a services and staffing company. We do not manufacture or market drugs or devices; we provide the regulatory, clinical, safety, quality and data specialists our clients need to do so, and we take on defined scopes of that work under a statement of work.

Every pharma service below can be bought three ways: an individual consultant placed into your team, a Vakula-managed team delivering to an agreed scope, or an ongoing functional service with SLAs. Tell us the problem and we will recommend the model that fits.

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Nine services

Pharma Services

01

Regulatory Affairs

Submission strategy, authoring, agency interaction and lifecycle maintenance.

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02

Clinical Research

Protocol-to-CSR support, clinical operations and study delivery.

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03

Pharmacovigilance

Case processing, aggregate reports, signal detection and PV systems.

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04

Validation & CSV

CSV, IQ/OQ/PQ, Part 11 and data integrity for GxP systems.

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05

Biostatistics

SAPs, SDTM/ADaM programming, TLFs and data management.

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06

Trial Management

Study planning, site and vendor management, data management.

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07

Trial Monitoring

Risk-based, centralised and on-site monitoring.

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08

GxP Audit & Quality

Site, vendor, process and TMF audits; inspection readiness.

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09

Clinical Project Management

Experienced clinical PMs who keep studies on plan and on budget.

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Start with one requirement.

Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.

Contact us+1 (848) 488-9836
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