Regulatory Affairs

Global Regulatory Expertise

Clinipace Worldwide offers you a team of multi-national Regulatory Affairs professionals who have vast experience working with competent regulatory authorities around the world. Our regulatory expertise ensures that regulatory strategies and alternatives are considered at every step to help you gain product registration, and include the following areas:

• Regulatory Affairs
• Clinical Trial Applications and Product Registrations
• Regulatory Publishing
• Regulatory Writing
• Legal Representation

Regulatory Affairs

This team will work with you in both pre- and post-marketing drug safety regulations, document management, regulatory filings, global marketing authorization applications, variations and renewals and carefully developed due diligence strategies.

Our Regulatory Affairs services include:

• Review of client technical dossiers and developmental plans
• Research and interpretation of applicable local regulations
• Determination of regulatory status
• Review and support of manufacturing/GMP issues
• Pre-submission review of technical documents
• Critical writing and review of documentation
• Clinical trial applications and notifications (IND, IDE, CTX, etc.)
• Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
• Orphan Drug, Treatment Use, and ANDA Suitability petitions
• Company representation before regulatory officials

Clinical Trial Applications and Product Registrations

Our experience encompasses US FDA and international clinical trial applications, and registrations of new chemical and biological entities, as well as those products containing established pharmaceutical ingredients (generics and 505(b)(2) products). We develop high-level regulatory strategies to expedite products through clinical trials and into the market, and regularly represent our clients in meetings with the US FDA and international regulatory authorities. Clinipace can act as the US agent for overseas companies.

Using mutual recognition or centralized procedures, we can manage the entire European registration process for new medicinal products as well as for generic products. We have extensive experience writing Drug Master Files for international product registrations.

Regulatory Publishing

Clinipace Regulatory Operations supports the production of submissions in both paper (“old” and CTD formats) and electronic formats. Whether you are submitting an original IND, NDA or ANDA, or an amendment, supplement, or variation to an existing application, or converting an existing application to eCTD format, we can publish and deliver an FDA/ICH-compliant submission to meet your needs.

In the ever changing world of regulatory submissions, we work with industry leaders to stay at the forefront of eCTD requirements. By using our own highly qualified and experienced staff to perform most of the e-publishing, and limiting the use of third party e-submission vendors to highly specialized activities, we can offer affordable e-submissions to our client companies, regardless of the size of their company. Our publishing team works closely with the authors to ensure documents are written using industry templates with the appropriate granularity, and to ensure formatting consistency across the dossier. Throughout all stages of submission preparation, consideration is given to the potential lifecycle management of the application to ensure that accommodations to future changes and amendments can be made with little or no disruption to the overall message of the application.

Clinipace Worldwide prepares all major regulatory submissions and provides extensive quality control review for all trial related documentation, such as:

• Regulatory Agency and IRB/EC submissions
• Procurement of Import/Export license, as applicable
• Initial submissions, amendments, notifications, and closeout submissions
• Clinical trial agreements and contracts (site, investigator, laboratory, etc.)

Working as a collaborative team, our regulatory specialists coordinate all aspects of your trial's document collection and submissions, including:

• Manage all regulatory documentation as part of the start-up, conduct, and close-out phases
• Coordinates Informed Consent Forms (ICF) processes to ensure study sites meet local requirements
• Coordinates all document translations
• Coordinates clinical trial application filings to domestic and international regulatory agencies
• Ensures submissions comply with applicable local regulations
• Manages submissions and document storage processes
• Stays abreast of all regulations to ensure documentation compliance

Regulatory Writing

Our medical and technical writers prepare expert reports, summaries, investigator brochures, protocols and clinical study reports to meet regulatory authority requirements. Our team of experienced regulatory scientists can write the nonclinical, clinical and CMC sections in CTD and traditional format for your new drug and biologic applications. We have extensive experience writing Drug Master Files for international product registrations.

Legal Representation

Clinipace Worldwide regulatory consultants provide legal representation for clients in their interactions with competent authorities across the globe. Our consultants have represented clients and are authorized to act as their legal entity with the following authorities: