Regulatory Support

At Shoshin Pharma, we understand the critical role of regulatory compliance in the pharmaceutical industry. Our dedicated Regulatory Affairs team ensures that all our products meet the highest standards of safety, efficacy, and quality, complying with global health authority requirements.

Our Regulatory Services Includes:

• Dossier Preparation:
  We offer end-to-end support in compiling all necessary technical, clinical, and quality documentation required for pharmaceutical dossier submissions. This includes the preparation of Common Technical Documents (CTD) for regulatory authorities in various markets.

• Regulatory Compliance:
  Our regulatory experts stay abreast of the ever-changing regulatory landscapes in different regions, ensuring that all documentation meets the latest guidelines and legal frameworks for major regulatory bodies.

• Country-Specific Customization:
  We tailor each dossier to meet the specific regulatory requirements of individual countries or regions, whether for the, Latin America, Asia, or other emerging markets. This ensures swift approval and market entry in a wide range of jurisdictions.

• Streamlined Approval Process:
  Our proactive approach minimizes regulatory delays and accelerates the product approval process. By closely working with regulatory authorities and leveraging our in-depth knowledge, we help expedite time-to-market for our partners.

• Expert Handling of Variations and Renewals:
  We manage regulatory variations, updates, and renewals, ensuring that products remain compliant with any regulatory changes during their market presence. Our team also handles any additional post-approval amendments to maintain product licenses.

• Regulatory Submissions Across Multiple Markets:
  With extensive experience in multi-country dossier submissions, we facilitate smooth entry into multiple global markets simultaneously, helping our partners expand their reach.

With our expertise in global regulatory frameworks, we help our partners achieve timely product approvals and maintain compliance across multiple markets.