Overview
 
Regulatory Affairs Services

Whatever the scale or complexity of your project, Regulus has the contacts and the knowledge to maximize your chances of success with regulatory authorities across the world. Our RA team offers expert advice and produces high-quality submissions to meet worldwide regulatory requirements. We have developed strong relationships with the US Food and Drug Administration as well as other regulatory agencies, and regularly represent our customers at critical agency meetings.

Frequent, direct interaction with the US Food and Drug Administration puts us in a strong position when preparing and submitting investigational new drug applications and US marketing applications for pharmaceutical, biotechnology, and generic products. Using the Common Technical Document format and following mutual recognition or centralized procedures, we can manage your global registration process.

Regulus RA can work with you to establish your product development strategy to allow you access to the widest possible market in the shortest possible time. We can conduct due diligence of potential acquisitions and product opportunities.
 
Quality Assurance Services

Regulus QA provides expert services to pharmaceutical, biotechnology, and dietary supplement companies. Whether you are looking to develop and implement quality systems from scratch, or need to standardize and review the compliance of your existing systems, or your contractors’ systems, Regulus QA’s experienced team of auditors can help you.

We can perform a detailed assessment of your existing quality systems and processes, to highlight problem areas and recommend improvements, so that you can build quality systems that are appropriate for your company’s stage of development. Regulus QA can provide a comprehensive range of auditing services for all laboratories, to meet global GLP and GMP requirements.

We also offer expert advice and guidance in laboratory quality issues, assist with the establishment of quality management systems, the preparation of laboratory policies and SOPs, and the planning of routine monitoring and QC procedures. In addition, we can conduct GMP audits of process development and formulation laboratories, as well as manufacturing and packaging facilities. We can also conduct similar activities on your behalf for third-party contractors. We also perform GCP audits of clinical protocols, investigator sites, master files, pharmacovigilance, databases and reports.
 
Regulus Consulting Team
Regulus’ management team has been together since the late 1990’s when they were employed in the Regulatory and Quality departments of a specialty pharmaceutical company. After being established in 2003, Regulus has expanded through the strategic recruitment of industry-experienced professionals to provide a unique resource of experience and skills to meet the requirements of pharmaceutical and biotechnology clients in the manufacturing, nonclinical, clinical, regulatory affairs, project management and medical/technical writing areas.

Regulus personnel have extensive pharmaceutical knowledge gained from senior positions in pharmaceutical and biotechnology industries. With an average of over 15 years’ industry experience, members of our team can provide expert advice covering nonclinical to clinical activities to manufacturing, marketing, and post-marketing support.

In addition to our Regulatory Affairs and Quality Assurance consultants, we have an in-house publishing group that can prepare electronic or paper dossiers for worldwide regulatory submission. Our medical/technical writing personnel can produce grant applications, manuscripts, and articles for publication, as well as ICH-compliant clinical documents. To complete our services, we have in-house Quality Control personnel to monitor the quality of our regulatory submissions as well as perform internal and external audits against current GMP, GCP and GLP regulations.

Our organizational structure has been developed to encourage the exchange of ideas and best practice among our staff, as well as to ensure that all the relevant disciplines are involved in a project, from initial concept through to the final delivery of the completed project to the client. Each client is assigned a dedicated project manager who is responsible for monitoring the project against timelines and budget, and who is the primary point of contact with the client’s designated representative. Depending on the expertise needed for the project the Regulus team can be supplemented from our network of proven, high caliber consultants. In addition, Regulus personnel frequently work in collaboration with, or manage other contract research organizations in order to provide the best possible team of experts for its clients.