Regulatory affairs, operations, and CMC services

Engaging with health authorities worldwide can increase the likelihood of market approval and positively impact development timelines and costs. To support this, we regularly assist our clients in interacting with health authorities throughout a product's life cycle.

By initiating these discussions early in the development process, our clients can promptly identify and address potential risks and weaknesses in their development plans. This process involves coordinating and preparing pediatric development plans and orphan drug designation applications, as needed. It also includes determining the most suitable application strategy, such as considering accelerated approval pathways or international reliance procedures, to facilitate efficient submissions.

With consultants across the globe, we offer an integrated solution combining the scientific, technological, and regulatory expertise with our broad global experience to meet your specific needs, from discovery to licensing and post-approval. Recognizing that every company is unique, we offer flexible, tailor-made solutions to meticulously plan and support every aspect of your drug development life cycle.

Our comprehensive Chemistry, Manufacturing, and Controls (CMC) services span the entire product life cycle, supporting regulatory compliance and facilitating efficient market access. We provide end-to-end CMC consulting for small molecules and biologics, covering both drug substance and product, from early development through post-approval stages.

In early development, we specialize in CMC strategy, analytical and formulation development, process development, dossier authoring, and expert reports to prepare for initial regulatory steps, such as health authority meetings or scientific advice. We excel in authoring, updating, and reviewing Quality sections of dossiers for regulatory applications, such as:

• IMPDs/INDs
• ASMF
• CEP
• DMF
• MAAs
• BLAs/NDAs/ANDAs
• renewals
• annual reports
• variations
• PACs
• expert Quality and CMC reports

Our expertise includes conducting due diligence and gap analysis to achieve CMC compliance with regional guidelines (EMA, FDA, etc.) and current practices.

Globally, we are strong in post-approval CMC activities, managing CMC changes, including change control assessments, filing strategies, and responding to health authority requests post-submission. We guide clients through major internal projects, such as manufacturing site and technology transfers, leveraging our expertise in CMC and Quality compliance. For CMC compliance and remediation projects, we offer support based on a risk assessment model, from identifying red flags to in-depth analysis, strategy preparation, and managing remediation measures until approval.

Whether during development or post-approval, we offer expert guidance on preparing clinical trial authorization applications and the necessary documentation for health authorities and ethics committees or institutional review boards. This includes assistance in navigating complex documentation requirements and authoring patient materials.

We have extensive experience with clinical trial authorization (CTA) applications and IVD performance study submissions. Our in-depth understanding of the EU Clinical Trial Regulation makes us the preferred partner for these activities. Additionally, we provide support with technical review and updates of core documents, such as:

• protocol and IB
• redaction of Part II documentation (CCI and PPI)
• authoring lay summaries
• study registration
• end-of-trial activities, including the authoring and posting of summary results.

Our experts have a proven track record in authoring submission dossiers, navigating submission procedures, and delivering timely responses to agency questions, leading to the approval of marketing authorization applications (MAAs) across applicable regions. Our team of seasoned regulatory experts coordinates the entire submission process, efficiently managing input from all stakeholders to cover modules 1-5, creating an organized and aligned process that optimizes timelines.

We provide regulatory expertise at every stage to meet regional and national requirements in line with current legislation and company objectives. Post-submission, we emphasize regular interaction and alignment with health authority representatives to manage procedures effectively and address any authority requests or questions until country-level approval is achieved.

Our experts have extensive knowledge and practical experience in authoring and developing product information and labeling documentation throughout the product life cycle.

We provide comprehensive labeling support, managing global and regional requirements, compliance, technology needs, proofreading, and translation services. Our expertise covers the development and maintenance of core labeling documents such as company core data sheets (CCDS), tracking and monitoring key milestones like CCDS periodic reviews, aligning CCDS with regional labels, communicating with health agencies for labeling negotiations, describing CCDS changes, tracking local deviations, managing artwork, conducting readability user testing and bridging reports as necessary, and performing proofreading.

We recognize the dedication required to reach the point of submitting dossiers to authorities. Our specialized regulatory informatics and operations services encompass all aspects of dossier management and beyond.

Electronic submission services
Our electronic submission experts support clients globally with operational activities, including: facilitating the readiness, compilation, publishing, and validation of initial and life cycle management dossiers. We handle key regions and submission types, complementing activities with in-house regulatory systems. Our proficiency includes dossier dispatch to authorities, archiving, document management, and regulatory information management.

Informatics services
We recognize increasing demands and expectations for quality regulatory data. Our experts assist in creating, revising, and maintaining regulatory information to support business processes and informed decision-making. We provide EMA system support and keep xEVMPD and SPOR databases up-to-date. We help clients optimize processes, configure systems for maximum benefit, and reduce operational challenges of validated GxP-relevant RIM systems. Our regulatory informatics experts design optimal processes to enhance technological advantages while ensuring compliant and efficient data management.

Additionally, we maintain partnerships with leading regulatory informatics and operations companies.

Our post-approval solutions offer trusted, strategic methods that keep your product compliant and advancing, supplemented by hands-on regulatory support. Whether you need to outsource regulatory lifecycle maintenance, seek support during mergers and acquisitions, or require local regulatory affairs assistance, our solutions deliver tailored, compliant, and efficient models known for their flexibility and cost-effectiveness.

Our service portfolio includes comprehensive life cycle management and maintenance services across key regions:

• CMC and safety variations
• renewals
• de-registrations
• periodic safety update report (PSUR) submissions
• risk management plans
• direct healthcare professional communications
• CCDS revisions and roll-outs (including translations)
• referral procedures
• handling post-approval commitments
• managing marketing authorization (MA) withdrawals
• support in communication and handling of potential drug shortages

We define and organize global roll-out strategies for post-launch activities, working closely with adjacent departments to lead and drive the respective teams.