Regulatory Consulting Navigate Regulatory Complexities with Confidence—From Development to Post-Approval

 

At OriPeutic BioServices, we partner with life science companies to navigate the evolving global regulatory landscape across the entire product lifecycle. From early development to commercial launch and post-marketing maintenance, we provide the strategic insight, operational expertise, and regulatory rigor necessary to accelerate your path to approval and market success.

 

Regulatory Challenges Require Proven Experience—We’ve Walked in Your Shoes

 

With increasing global regulatory expectations (e.g., FDA 21 CFR, EMA, ICH Q12, and others), every detail in your application and quality system matters. Our team includes former industry and agency experts who understand both what regulators want and how to deliver it—whether it’s for NDAs, BLAs, INDs, or MAA filings.

 

What We Do

Regulatory Submission Support

• CMC dossier authoring (Module 3 and regional requirements)

• eCTD publishing and submission support

• PAI readiness and gap assessments

• Post-approval CMC management: supplements, annual reports, CBE-30, CBE-0

Regulatory Strategy Development

• CMC strategy for development, tech transfer, and lifecycle

• Filing strategy (IND, NDA, BLA, ANDA, MAA)

• Specification setting and justifications

• Comparability protocols and bridging strategies

• Preparation and representation during health authority meetings

Product Development Guidance

• Quality by Design (QbD) and Question-Based Review (QbR) frameworks

• Continued Process Verification (CPV) planning

• Integration of regulatory expectations into development and validation strategies

Sustainable Compliance, Built for the Long-Term

Our highly credentialed consultants bring decades of experience in regulatory affairs, quality systems, and product development. We don’t just interpret regulations—we help you operationalize them, embedding regulatory intelligence into your process to minimize delays and maximize success.

• Trusted by global pharma, biotech, and device firms

• Experienced in U.S. FDA, EMA, and ICH frameworks

• Focused on efficient filings, regulatory alignment, and inspection readiness

 

 

Let’s Accelerate Your Regulatory Journey

OriPeutic BioServices gives you a strategic edge—guiding your regulatory filings, interactions, and quality systems for long-term success in a competitive and regulated environment.