Contract Regulatory Staffing Services

Subject Matter Expertise driven, Seamless staffing services excellence in key global markets across Regulatory Affairs, Clinical, Pharmacovigilance and other pertinent compliance functions.

Services We Offer

Why Artixio For Your Regulatory Staffing Services?

Get access to Artixio’s expert regulatory, clinical and other consultants on contingent or direct hire candidate through Staffing Services. Artixio’s industry experience in successfully supporting large-scale, global operations right from drug/device development to post market maintenance positions it in understanding the ultimate business objectives and to align with your staffing strategy. We support staffing across regulatory affairs, regulatory operations, clinical, pharmacovigilance, advertising and promotional material review, labelling, artwork, quality, medical affairs and others.

Product Development → Registration → Post Market Maintenance

Our Process:

Client share requirements (Business Objective, Locations, Roles, JDs, Budget, Timelines, Tenures)
Strategic Discovery (Technical, Business Evaluation, Suitable Business Models)
Regulatory Information Management
Candidate Evaluation (Inhouse & Network (Oasis))
Client One-on-Ones
Contracting
Onboarding
Periodic Evaluation for Back-up, Replacement Strategy

Key Functions and Roles Supported:

Regulatory Affairs
Publishing
Labeling
Ad Promo Review
Artwork & Labeling Proof Reading Quality Check
Clinical Trial Management
Market Access
Pharmacovigilance
Regulatory Information Management
CMC
Change Coordination
Regulatory Intelligence

Experienced, Qualified Network of Professionals

Artixio provides qualified resources in timely manner for your ongoing regulatory affairs, operations needs on a short-mid and long term basis. Our wide network of experts include experienced professionals for Senior, Mid and Junior level positions across regulatory, quality and safety positions. The representative resources pool include,

Your Global Partner for Regulatory and Safety Staffing:

Deep cross functional expertise supporting Pharma Development and Post Approval Maintenance
Contingent and Long-Term Staffing
Wide global professional network of professionals with proven experience
Experience based, data driven resources qualification for the role
Inhouse / External pre-qualified candidates across seniority levels
One-on-one discovery of potential between clients and candidates
Big picture understanding for wholistic solutions
Flexible tenures and business model: Hourly, Monthly, Quarterly, Annual
Quick Turnaround
Reliable, long term partnership approach
Backup and replacement planning for business continuity
Standardized, quality driven processes and contractual instruments
Seamless onboarding and program initiation with client specific process and systems training

FAQs

What are key components of global Regulatory staffing?

A promising Regulatory, Clinical, Pharmacovigilance staffing strategy includes,

Understanding of both business and functional situation in a company. Regulations and technical requirements vary significantly across functions (such as Regulatory Affairs, CMC, Quality, Labelling etc.), across product types (such as new chemical entities, generics, combination drugs, biologics, biosimilars, OTC etc), therapeutic areas (such as oncology, cardiovascular, speciality pharma, dermatology, ophthalmic) and dosage forms (such as tablets, injectables, topicals etc).
Strong network of experienced professionals for varied requirements, a strong pipeline of candidates available who are vetted for both their technical and professional skills are key to right staffing strategy.
Operational experience and insights around global operating environment, cultural and language nuances, country specific regulations for human resource management
Fast turnaround while focusing on quality
Time saving for clients by leveraging domain experience, pre-qualified pipeline, standardized processes and seamless onboarding experience

How do you support Regulatory staffing across multiple countries?

Artixio has presence in key markets globally. In addition, we also work with specialized, senior experts across functions in leading countries in contract model to support on ground staffing for various regional requirements such as regulatory affairs, clinical trial management, pharmacovigilance, market access and other areas.

What does Artixio’s flexible tenure and staffing model include?

Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

What challenges do companies face in global regulatory staffing and how do you address them?

International pharma and device companies have their products marketed in the foreign countries or they are planning for clinical trials and registration of products in new markets. They often face challenges in setting up a local team, maintaining a full fledged team due to business potential and ROI, finding the right experienced local experts, business strategic decision to maintain contract staff, sudden increase in work volume or employee leaves leading to contingent staff requirements.

Artixio addresses these challenges by offering solutions that meet companies’ strategic and tactical business requirements by providing highly qualified professionals with proven experience specific to the function/domain in timely and cost effective manner using flexible hourly, weekly, monthly or annual contract model leveraging its global team and network of pre-qualified experts.