About SciReg

SciReg Consulting is a experienced pharmaceutical consultancy specializing in Good Manufacturing Practice (GMP) compliance, quality control (QC) laboratory management, and Regulatory Affairs. With a strong background as in GLP and GMP, we ensure pharmaceutical products, like biologicals, meet stringent FDA and EU GMP quality and regulatory requirements before market distribution.

Beyond GMP and QA/QC expertise, SciReg Consulting provides strategic guidance in Regulatory Affairs and toxicology assessments, helping clients navigate complex regulatory landscapes, optimize compliance strategies, and mitigate risks. SciReg expertise supports pharmaceutical start-ups in achieving regulatory approvals, maintaining compliance, and upholding product safety and efficacy standards.

Supporting the Transition from Research to GMP-compliant Manufacturing

SciReg Consulting offers specialized support for companies moving from research and clinical-stage manufacturing to full GMP-compliant production, ensuring alignment with FDA (21 CFR Part 210/211) cGMP regulations and EudraLex Volume 4 GMP guidelines.

Key areas of expertise include:

  • Implementing GMP-Compliant Manufacturing Processes – Supporting the transition from non-GMP to GMP production, including process validation and scale-up strategies.

  • Quality Management System (QMS) Development – Establishing robust cGMP-compliant quality systems tailored to company needs, ensuring compliance with FDA and EU regulatory requirements.

  • Regulatory & Compliance Support – Providing strategic guidance to meet global regulatory expectations for clinical and commercial manufacturing.

  • Risk Management & Process Control – Identifying critical control points and implementing quality risk management strategies to maintain product integrity.

  • Technology Transfer & Validation – Ensuring a seamless transfer from development to GMP production through structured process validation and documentation best practices.

Platzhalter

With deep expertise in quality assurance, regulatory strategy, and process implementation, SciReg Consulting empowers pharmaceutical and biotech companies to navigate the complexities of early-stage product development, clinical-to-commercial scale-up, and GMP transition while ensuring full regulatory compliance.

Looking for expert guidance in GMP transition, clinical-to-commercial scale-up, or QMS implementation? SciReg Consulting provides tailored solutions for success.