Regulatory Compliance

Regulatory-Compliance-Report-Review-FDA-Europe

  • Comprehensive support for the entire product lifecycle, from product development to post-market surveillance

  • Assistance with labeling requirements, safety assessments, and product registration/notification

  • US FDA > US Agent (MoCRA)

  • Notify Health Canada > Cosmetic Notification Form (CNF)

  • Help facilitate CPNP Notification

  • Facilitate compilation of Product Information File (PIF)

  • Formulation review to ensure compliance with Reg (EC) No 1223/2009

  • Formulation review to ensure compliance with the ASEAN Cosmetic Directive (ACD)

  • Label review

  • Customized services to meet your specific regulatory needs, ensuring timely and efficient compliance with all applicable regulations

  • Provide expert guidance throughout the compliance process

Frequently Asked Questions

  • Compliance with regulations and laws is the process of adhering to government agencies' and industry's regulations. Scipex, regulatory compliance involves assisting clients in navigating and meeting specific regulatory requirements such as EU regulations, FDA guidelines, and international standards.

  • Regulatory compliance is vital for businesses to maintain integrity, avoid legal penalties, protect their reputation, and gain a competitive advantage. It demonstrates a commitment to ethical practices, fosters trust with customers and stakeholders and helps mitigate risks associated with non-compliance.

  • SCIPEX specializes in providing regulatory compliance services to support businesses across various industries. Our team of experts offers comprehensive guidance on interpreting and implementing regulatory requirements, conducting compliance audits, developing compliance strategies, and assisting with regulatory submissions and reporting.

  • SCIPEX covers a wide range of regulatory requirements for various industries, including but not limited to cosmetics and consumer products, chemicals (REACH, CLP, GHS), and more. We stay updated with evolving regulations to provide accurate and timely compliance solutions.

  • If you are seeking regulatory compliance services from SCIPEX, you can visit our website at www.scipex.com and explore our Contact section. There, you will find information on how to contact SCIPEX and discuss your specific compliance needs. Our team will work closely with you to understand your requirements and tailor a solution that aligns with your business objectives.