Our services
Regulatory Strategy & Certification Readiness
SciReg supports companies in navigating complex regulatory landscapes and preparing for critical certifications, ensuring that strategic decisions and operational structures align with global regulatory standards. Whether entering new markets, applying for funding, or targeting formal certification, our expert guidance helps lay the foundation for long-term compliance and market success.
SciReg provides support in the following areas:
ISO 13485 and GMP certification planning, including GAP analyses, resource assessments, and implementation roadmaps tailored to start-ups and scaling manufacturers.
Regulatory documentation development, such as technical files, and site master files in accordance with EU, FDA, and ICH expectations.
Audit readiness and mock inspections, preparing teams for notified body or authority inspections with documentation reviews, CAPA systems, and facility walkthroughs.
Compliance roadmaps for EU funding programs, aligning project proposals and execution plans with regulatory requirements and sustainability goals.
Regulatory intelligence & strategic positioning, analyzing current regulatory trends and integrating them into early product development, process changes, or market expansion strategies.
With SciReg’s strategic support, your organization gains the foresight and structure needed to achieve compliance, reduce certification timelines, and minimize regulatory risk.
Transition to cGMP Manufacturing
SciReg specializes in seamless transitions from Research Use Only (RUO) to Good Manufacturing Practice (GMP), ensuring products meet regulatory and quality requirements for commercialization. Unlike general contract QA services, which focus on compliance oversight, RUO-to-GMP support involves strategic process transformation, aligning research-grade operations with regulatory expectations for manufacturing.
SciReg´s offers the following services:
Gap assessments to identify necessary process, documentation, and infrastructure upgrades for GMP compliance.
Quality Management System (QMS) development, including document control, deviation handling, and change management.
Process validation and equipment qualification, ensuring manufacturing consistency and regulatory adherence.
Method validation and analytical transfer, bridging RUO assays to GMP-compliant analytical methods.
Personnel training programs focused on GMP documentation, quality culture, and compliance expectations.
Regulatory guidance and audit preparation, supporting FDA, EMA, and other regulatory body requirements.
Through a structured, risk-based approach, SciReg ensures organizations efficiently upgrade from RUO to GMP, reducing compliance risks and expediting product commercialization.
Contract Quality Assurance
SciReg provides expert contract Quality Assurance (QA) support to ensure a smooth transition from Research Use Only (RUO) to Good Manufacturing Practice (GMP) compliance. With deep expertise in regulatory requirements, quality systems, and risk management, SciReg offers tailored QA services to meet your needs.
SciReg is available to serve as a third-party Quality Assurance Unit or as a QA resource on a project-by-project basis. The QA supervision can decrease time to GMP compliance and includes, but is not limited to, the following services:
Conduct quality assurance inspections (GLP/GMP) of study protocols, reports, raw data, and laboratory operations.
Detect compliance issues, recommend corrective actions, and assist in their implementation.
Perform facility audits and identify opportunities for process improvements.
Develop and deliver Good Manufacturing Practice (GMP) training programs, including mock inspections.
Review scientific data to ensure compliance with international regulatory guidelines.
Prepare, review, maintain, and distribute Standard Operating Procedures (SOPs).
With a focus on robust compliance documentation and regulatory alignment, SciReg helps companies reduce compliance risks and accelerate market readiness procedures.
Service Overview
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Service Overview :::
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