Regulatory and Medical Writing Solutions
Strategic Planning
Our strategic planning expertise includes: strategic regulatory advice, scientific and safety consulting, product development plans, expertise in all major therapeutic areas and experience with pharmaceuticals, biologics, and advanced therapies.
Submission Planning
Our regulatory submission planning covers: Investigational New Drug Application (IND), Investigational Medicinal Product Dossier (IMPD), Clinical Trial Applications (CTA), New Drug Application (NDA), Marketing Authorisation Application (MAA), Common Technical Document (CTD) and Electronic Common Technical Document (eCTD).
Regulatory Agency Meeting Support
We provide regulatory agency meeting support with the FDA, EMEA and other national regulatory agencies. Our regulatory agency interactions include: meeting planning, preparation and presentation, advisory meeting support, scientific advice, direct interactions with regulators, dispute resolution, pre-meeting briefing packages, post-meeting issue analysis and responses, and SAE reporting strategy buy-in with regulatory agencies.
Regulatory Services
Our regulatory team provides: document review of investigator documents, electronic publishing services, submission maintenance activities to regulatory authorities, document quality control, Chemistry, Manufacturing and Control (CMC) documents, risk management assessment, eCTD assistance/process mapping, regulatory application procedure management (including fast track, accelerated approval, rolling review, conditional approval), regulatory education and training, product lifecycle management, regulatory assessment and gap analysis, due diligence auditing, advertising and promotional material review, product information and labeling.
Clinical Trial Support
Our clinical trial support includes review of investigator packets required for the release of investigational products; development and review of consent forms; up-to-date knowledge and meeting regulatory requirements for specific countries and regions. The global regulatory team leader helps to ensure efficient and timely clinical trial start up.
Medical & Scientific
The medical and scientific writing services we provide are compatible with ICH guidelines and regulatory requirements. We write clinical study reports, trial protocols and amendments, manuscripts, literature reviews, investigator brochures and patient narratives. We also write regulatory submissions such as INDs, IMPDs, Investigational Device Exemptions (IDE), CTAs, CTDs, NDAs, Biologics License Applications (BLAs), New Drug Submissions (NDS) and Marketing Authorisation Applications (MAAs) in electronic (including eCTD) or paper formats. Along with our high level of internal quality control for our writing projects, we also provide you with integrated summaries of safety and efficacy and product development plans.