Vakula Technologies Inc was incorporated in November 2021, with its office at 15 Corporate Place South, Piscataway, New Jersey. The company was formed to do one thing well: supply experienced regulatory, clinical, pharmacovigilance, validation, biostatistics and information technology professionals to US pharmaceutical, biotechnology, medical device and technology organisations, and to take on defined scopes of that work when clients prefer to buy the outcome rather than the person.
Why two practices under one name
Life sciences companies buy IT and pharma services from different vendors and then spend months getting them to work together. A validation engineer who does not understand the LIMS, or a cloud architect who has never heard of Part 11, slows a programme down. Vakula was set up so that both kinds of specialist come from a team that understands the regulated context.
How we engage
From the first day the model has been the same: an intake call with someone who works in the discipline, a written scope or a shortlist of named consultants within days, and an engagement lead who remains accountable for quality and continuity. Contract, contract-to-hire, direct hire and statement-of-work delivery are all available, and the employment model is agreed in writing before any interview.
What comes next
The first requisitions were in computer system validation and clinical operations, the two areas where US sponsors were shortest of experienced people as trials restarted after the pandemic. Over the following quarters we will use this page to share what we are seeing in the market and the regulatory changes our clients are preparing for.