Solutions
Management
Excellence
Affairs
& Predictive Analytics
Technology Solutions
Cognify™
- Cognify™ is Solstice’s strategic technology platform that forms the foundation for our tools and services. At its core, are two capabilities.
- Cognify WF - An advanced workflow automation framework incorporating focused software modules alongside both human and AI workload agents, to deliver transparent, consistent and highly efficient end-to-end compliance processes.
- Cognify DR - An optimised, secure, tenanted data repository that ingests, classifies, tags, stores and surfaces structured regulatory data alongside unstructured data, documents and the widest range of legacy data artifacts.
Cognify Regence PA™
- The Regence PA service is built on Solstice’s Cognify™ strategic technology platform and delivers the regulatory intelligence needed to ensure CMC compliance.
- Tightly focused on, and specifically purposed for, post-approval CMC compliance, risk assessment and change identification, Regence PA offers the flexibility of a traditional consulting approach but with greatly enhanced reliability, accuracy, speed and efficiency.
- Solstice’s Regence PA comprises the very best human expertise and leverages automated wide scanning and scope-tuned data harvesting faculties fused with machine learning extraction and classification capabilities to provide continual monitoring, categorisation, assessment and alerting.
Life Cycle Management
Supporting your product’s global journey beyond approval—managing regulatory obligations across markets and lifecycle stages to ensure enduring compliance and market presence
Post-Approval Compliance
We ensure post-approval compliance through the management of regulatory commitments, administrative changes, and regulatory information. Our Regulatory Information Management (RIM) capabilities ensure accurate, up-to-date data across systems—enabling global compliance, audit readiness, and efficient lifecycle oversight.
CMC authoring
We provide specialized CMC authoring support and advanced AI capabilities through Cognify™, enabling efficient preparation and maintenance of documentation for post-approval changes. This ensures regulatory compliance and alignment with global lifecycle strategies, including PLCM integration, follow-up obligations, and regulatory harmonization. Our FSP model integrates scalable resource deployment with rigorous quality standards to ensure compliant, fit-for-purpose CMC deliverables tailored to your regulatory and operational requirements
Variations
We manage regulatory variations and supplements to support post-approval changes in manufacturing processes, specifications, packaging, and labeling. Our expertise spans global submission types, including FDA’s PAS, CBE-30, CBE-0, and EMA’s Type IA, IB, and II variations—ensuring timely approvals and continued compliance across markets.
MA Renewal
We support timely, compliant renewals of marketing authorizations to ensure uninterrupted product availability. Our services include preparing and submitting renewal dossiers per regional requirements—such as EMA’s five-year cycle—while proactively managing timelines and coordinating globally with affiliates
Post-Market Surveillance
We deliver post-market surveillance support, including targeted literature monitoring, risk management planning, and the design of post-authorization studies (PAS). Through Regence, our regulatory intelligence solution, we provide timely updates on evolving regulations that impact your product portfolio—helping you stay aligned with post-approval commitments.
Gap Analysis
Our experts conduct post-approval gap analyses by reviewing regulatory intelligence, auditing RIM systems and data integrity, and aligning with ICH Q12 principles. We also assess internal stakeholder requirements to identify remediation needs that streamline variation management, enhance inspection readiness, and support continuous product oversight
Risk Management
Identifying and mitigating potential risks associated with the product. Driving continuous compliance and product robustness through risk-based change control, regulatory alignment (ICH Q9/Q12), real-world surveillance, and process optimization
Change Control
We manage end-to-end change control processes to ensure regulatory compliance and product quality across global markets. Our approach aligns with ICH Q10 principles, integrating change control within the pharmaceutical quality system (PQS). We conduct comprehensive regulatory impact assessments, classify changes according to regional requirements (e.g., FDA, EMA, WHO), and coordinate documentation, justification, and variation submissions. By embedding change control into cross-functional workflows and quality systems, we enable efficient implementation, traceability, and regulatory alignment throughout the product lifecycle.
Compliance Reporting
We deliver comprehensive compliance reporting solutions that support both internal governance and regulatory authority requirements. Our services include the generation of submission trackers, regulatory summaries, audit-ready documentation, and periodic compliance reports. Integrated with Regulatory Information Management (RIM) systems and real-time dashboards, our reporting framework ensures data accuracy, traceability, and visibility across global regulatory activities enabling proactive compliance monitoring and informed decision-making.
Data management
We support end-to-end regulatory data management with a focus on compliance, interoperability, and data integrity. Our services include standardizing data in alignment with IDMP (Identification of Medicinal Products) and SPOR (Substance, Product, Organisation, and Referential) requirements, integrating regulatory data across RIM, safety, and quality systems, and establishing robust data governance frameworks. We ensure high data quality through validation protocols, controlled vocabularies, and master data management enabling regulatory readiness, streamlined submissions, and future-proof digital compliance.
MedTech post approval Regulatory support
We support Post-market literature surveillance, Post-market Clinical Follow-up (PMCF), Annual maintenance of technical file (Clinical Evaluation Report (CER)/Risk Management), Regulatory renewals, New market launches and Competent Authority/Notified/Approved Body communication to ensure compliance post approval.
Talent Driven Excellence
Solstice offers flexible, scalable talent models to support global Pharmaceutical, Consumer, and MedTech companies — designed to meet the regulatory demands of today with the agility and precision required for tomorrow. We deliver value through five distinct engagement models:
- Regulatory Consulting: Access our senior regulatory experts for targeted, high-impact engagements — from strategy development to submission execution. Ideal for clients seeking specialized insight or short-term support.
- Augmented Teams: Add capacity to your internal teams with highly qualified Solstice staff. Our augmented team model embeds regulatory professionals who integrate seamlessly with your workflows and systems.
- Dedicated Teams: Establish a specialized Solstice team focused exclusively on your account. Ideal for organizations seeking continuity, scale, and operational control — with flexible resourcing across regions and functions.
- Capability Centres: Build high-performance teams with deep domain expertise, supported by centralized oversight, metrics, and QA. Designed for long-term engagements that require consistent delivery at scale and reduced cost.
- HyFlex Delivery: A hybrid model customized to your needs — combining consulting, embedded teams, and offshore resources to optimize cost, responsiveness, and global coverage.
Regulatory Affairs
Strategic Regulatory Affairs for Pharma, Consumer Health & MedTech. We help you navigate complex global regulations—supporting your product journey from development to market with expert guidance, streamlined compliance, and a focus on long-term success.
Regulatory Strategy and Planning
We design and execute end-to-end regulatory strategies that align with global business objectives and product lifecycle goals. Our region-specific roadmaps integrate clinical, nonclinical, and CMC development plans to meet regulatory expectations. By leveraging early engagement, scientific advice, and gap assessments, we proactively identify and mitigate regulatory risks. We embed regulatory requirements into Target Product Profiles, development milestones, and submission planning to ensure cross-functional alignment. Our coordinated dossier strategies drive global launch readiness and accelerate market access.
Dossier Preparation and Submission
We offer end-to-end regulatory dossier preparation and submission services across IND, NDA, BLA, ANDA, and MAA pathways, ensuring global compliance and accelerated approvals. Our expertise spans regulatory strategy, CTD/eCTD authoring (Modules 1–5), CMC documentation, and FDA/EMA meeting support. We specialize in 505(b)(1), 505(b)(2), and ANDA submissions, including labeling strategy, REMS planning, and post-submission lifecycle management—delivering high-quality, submission-ready content aligned with regional requirements and ICH guidelines.
CMC Authoring
We deliver high-quality CMC documentation for global regulatory submissions through streamlined Module 3 authoring. Powered by our AI-enabled, Cognify™ platform and supported by experienced regulatory writers, we ensure consistency, compliance, and efficiency across global applications. Our flexible delivery models—including scalable FSP and dedicated FTE support—enable seamless integration with sponsor teams, accelerating timelines and enhancing submission readiness
Labelling Compliance
We ensure compliance with labelling regulations, labelling updates, and labelling intelligence. Our solutions include verification of key label components—such as dosage, storage, warnings, and serialization—alongside Structured Content Authoring (SCA) support for SPL, IDMP, and ePI formats. With metadata tagging and content reuse strategies, we enable global harmonization. We also manage label lifecycle updates, including impact assessments, version control, and audit trail documentation.
Quality Management
We provide comprehensive services to establish, maintain, and optimize Quality Management Systems (QMS) and ensure GxP-compliant documentation across regulated environments. Our solutions are designed to meet the stringent requirements across GxP domains, supporting global regulatory readiness and operational excellence. Our experts design tailored quality systems to meet client-specific requirements, ensuring robust documentation (SOPs), effective process controls, continuous improvement, and proactive risk management.
Health Authority Consultation
We provide strategic and operational support for engaging with global regulatory agencies to obtain guidance, alignment, and approvals. Our services include proactive planning and execution of agency interactions—drafting briefing documents, coordinating meeting logistics, and managing formal communications. We support end-to-end query management, including tracking, analyzing, and responding to health authority questions to ensure timely and effective resolution.
Gap Analysis and Remediation
We offer Regulatory Gap Analysis and Remediation Services to help identify compliance gaps and implement corrective actions across regulatory submissions, quality systems, and documentation. Our Gap Analysis services include baseline assessments of dossiers, SOPs, and technical files against current regulatory frameworks such as FDA or EMA. We evaluate legacy products for alignment with evolving standards like ICH Q12 and EU Variations while focusing on developing risk-based action plans, updating or authoring SOPs and regulatory documents, and managing change control through structured impact assessments.
Regulatory Due Diligence
Assessing the regulatory status of a company or product during a merger or acquisition. We offer Expert-led reviews of dossiers, correspondence, and regulatory risk—delivered through a blend of deep domain expertise and rapid team deployment.
MedTech pre-approval Regulatory support
We provide classification and regulatory intelligence to inform your regulatory strategy—covering market selection, submission pathways, design file development, and risk analysis.
Regulatory intelligence & Predictive Analytics
Our RI platform delivers curated regulatory intelligence and forward-looking insights that empower smarter decision-making across regulatory, R&D, and commercial functions. What Sets Regence RI™ Apart:
- Curated, Actionable Insights — Regence RI™ filters and contextualizes regulatory updates based on therapeutic area, geography, and product type.
- Predictive Policy Monitoring — AI-driven insight detection anticipates emerging requirements, guideline shifts, and competitive trends.
- Personalized Dashboards — Stakeholders receive intelligence tailored to their role and focus, improving internal alignment and decision-making.
- Integrated Decision Support — Regence RI™ connects intelligence with scenario planning and impact analysis to guide strategy — not just track activity.
Unlike traditional intelligence tools that simply aggregate data, Regence RI™ delivers what’s most relevant, when it matters — helping clients move from compliance-driven reaction to insight-led planning.
