Regulatory expertise can make or break a product’s journey to market. In this exclusive interview, Sandra Mosquera, Regulatory Affairs expert, shares how our proactive and integrated approach helps clients overcome regulatory challenges, streamline approvals, and stay ahead of global requirements. From development to post-approval, discover how Sofgen supports every step of the process with precision and confidence.

1. Can you walk us through the different stages of the regulatory process and explain how Sofgen supports its clients at each step? 

Regulatory Affairs participates from the very early stages of the product development process. At SOFGEN, we provide comprehensive regulatory support at every stage of this process, ensuring compliance, efficiency, and a streamlined pathway to market. Here’s how we partner with our clients: 

• Development Stage:  

We assist in identifying the most appropriate regulatory pathway for your product, ensuring alignment with the requirements of relevant Regulatory Agencies. Our team provides a detailed roadmap of regulatory requirements and offers expertise in preparing regulatory submissions, including support for bioequivalence study designs to demonstrate equivalence to reference listed drugs (RLDs). As a Contract Development and Manufacturing Organization (CDMO), we work collaboratively with our partners, providing tailored feedback to help achieve their market objectives. 

• Pre-Submission Stage: 
  SOFGEN helps compile a complete regulatory dossier, including critical modules such as chemistry, manufacturing, and controls (CMC). We perform gap analyses to ensure submission-readiness and provide support for appropriate submissions to the different Regulatory Agencies’ eCTD platform. 

• Submission and Review Stage: 
  If agreed, our team can liaise directly with the Regulatory Bodies (such as FDA) during the review process to promptly address questions and deficiencies. We prepare responses to Complete Response Letters (CRLs), Information Requests (IR), among others and offer strategic advice to expedite approval.  

• Post-Approval Stage: 
  Once your product is approved, we help manage post-approval changes, annual reporting, and compliance with regulatory post-marketing requirements to keep your product on the market without interruptions. 

2. What sets SOFGEN apart in navigating complex regulatory landscapes, and how do we ensure a smooth path to market for our clients? 

SOFGEN stands out due to our: 

• Extensive Expertise: 
  Our team has years of experience working with the FDA and other regulatory agencies, giving us a deep understanding of regulatory complexities and the ability to foresee and mitigate potential roadblocks.  

• Proactive Approach: 
  We stay ahead by identifying regulatory changes and updating strategies in real time, ensuring our clients remain compliant and competitive. Our Regulatory Intelligence system anticipates the regulatory landscape we will navigate, to set our plans to be successful.  

• Customized Solutions: 
  Every client’s project is unique. We provide tailored regulatory strategies based on your product's specifications, therapeutic category, and target market.

• Seamless Integration: 
  Our in-house capabilities across manufacturing, quality assurance, and regulatory affairs allow us to provide an end-to-end solution for a streamlined regulatory journey.  

By partnering with SOFGEN, clients experience reduced timelines and a hassle-free path to the market. 

3. How does SOFGEN stay updated with changing global regulations, and how does this benefit our clients in different markets? 

SOFGEN remains at the forefront of regulatory developments by: 

• Engaging with Regulatory Authorities: 
  We actively participate in FDA industry meetings, workshops, and public consultations.  

• Continuous Education: 
  Our team regularly attends training sessions and conferences, such as those hosted by FDA, Health Canada, DIA, RAPS, among others, to stay informed on emerging regulations. 

• Regulatory Intelligence System: 
  We have a dedicated monitoring system to track regulatory updates globally, ensuring our clients are informed of any changes affecting their products. 

This proactive approach allows us to provide regulatory guidance that aligns with the latest regulatory requirements and adapt submission strategies for evolving global standards, benefiting clients entering the expected markets. 

4. What are some common regulatory challenges in the pharmaceutical industry, and how does SOFGEN’s expertise help clients overcome them? 

Some common regulatory challenges include: 

• Stringent regulatory requirements: 
  Current high standards from regulatory agencies for application approvals can lead to extended review times, regulatory requests or CRLs. SOFGEN mitigates this by ensuring comprehensive, high-quality submissions and addressing agency feedback efficiently. 

• Post-Approval Compliance: 
  Managing changes to manufacturing processes or packaging can be daunting. Our team expertly handles post-approval submissions, such as CBE-30s and Prior Approval Supplements (PAS), minimizing risks of supply chain disruptions. 

• Evolving Regulations: 
  Keeping up continuous updates to FDA and ICH guidelines can be overwhelming. Our dedicated monitoring systems (Regulatory Intelligence) ensure that our clients remain compliant with the latest standards. 

• Global Market Access: 
  Navigating the unique requirements of international markets can delay expansion. SOFGEN leverages its expertise in multi-region regulatory submissions to help clients expand seamlessly into new territories. Our facilities and Quality Systems are also in GMP compliance with various regulatory bodies, including the US FDA and Health Canada, demonstrating the high level of compliance we have achieved. 

By addressing these challenges head-on, SOFGEN empowers clients to achieve timely approvals and maintain compliance, ensuring the long-term success of their products.