How quickly can you have a team operational?
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For standard engagements, we can have a qualified team identified and entering onboarding within two to four weeks of scope agreement. The onboarding period — during which your team is trained to your SOPs, access-provisioned to your systems, and quality-checked on outputs — typically runs one to two additional weeks depending on the complexity of your environment. For urgent requirements, particularly around pharmacovigilance coverage gaps, we can discuss expedited arrangements.
Do your teams work in our systems, or do you require us to use yours?
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We work exclusively in your systems. Whether you run Oracle Argus, Veeva Vault, Medidata Rave, a proprietary safety database, or a locally hosted document management platform — your team is trained and access-provisioned to operate directly within your existing environment. We do not require you to migrate to any platform we own, licence, or prefer. Our value is operational, not technological.
What qualifications do your pharmacovigilance professionals hold?
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Our pharmacovigilance professionals hold relevant life sciences degrees — B.Pharm, M.Pharm, PharmD, or BSc / MSc in biology, biomedical sciences, or a related discipline — and have hands-on operational experience in MedDRA coding, ICSR case processing, and safety database management. Most have two or more years of direct PV operations experience at CROs or pharmaceutical companies. Many hold additional certifications including CPVC, DIA Drug Safety credentials, or RAPS RAC designations. We match qualification profiles to your specific requirements and provide full CVs for your review before any team member begins work.
We are a small company with limited budget. Is there a minimum engagement size?
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No minimum. We work with companies of all sizes — from single-product specialty distributors managing GCC submissions through to mid-size pharmaceutical companies running multi-market post-marketing programmes. If your workload requires one dedicated professional or a full team of eight, we structure the engagement accordingly. Some of our most productive relationships are with small GCC commercial operations that have a single regulatory manager who cannot manage the full documentation workload alone.
How are engagements priced?
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We operate on fixed monthly retainers, priced per professional and engagement scope. This gives you entirely predictable cost and consistent delivery — without the ambiguity of billable hours, variable monthly invoices, or scope creep discussions. Pricing is agreed at the start of the engagement based on the specific roles, qualification levels, workload parameters, and markets involved. We provide a full written scope and service agreement before any work begins.
Can you handle MOHAP and SFDA submissions at the same time?
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Yes. Our regulatory teams are specifically trained in GCC health authority requirements and are experienced in managing concurrent submissions across MOHAP (UAE), SFDA (Saudi Arabia), DHA, Kuwait MOPH, Bahrain NHRA, and other regional regulators simultaneously. We understand the dossier variations, procedural differences, and timeline requirements between jurisdictions — and can act as a single point of accountability for a full GCC market entry programme, coordinating parallel submissions without requiring your internal team to manage each authority separately.