Our Innovative Process to Tackling Regulatory Challenges

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Our process streamlines regulatory pathways, boosting efficiency, compliance, and success through a blend of expertise and innovation.

Proactive Planning

Identifying challenges early and creating strategic roadmaps tailored to each product and market.

Comprehensive Analysis

Combining regulatory intelligence and in-depth data evaluation to ensure alignment with evolving requirements.

Collaborative Execution

Partnering with stakeholders and regulatory bodies for seamless submissions and approvals.

Technology-Driven Optimization

Leveraging advanced tools to streamline workflows, improve data integrity, and reduce time-to-market.

Continuous Adaptation

Staying ahead of regulatory changes to maintain compliance and agility in dynamic landscapes.

Our innovative process transforms regulatory challenges into opportunities, ensuring success at every stage of development and commercialization.

Regulatory documentation and submissions are essential for compliance in product development and commercialization. Below is a summary of key processes across major regions.

FDA Regulatory Pathways

Q Submission (Pre-Submission)

• Purpose: Obtain FDA feedback early.
• Documents: Cover letter, device description, questions, testing summary.
• Timeline: Submit 60-90 days prior.

510(k)

• Purpose: Show substantial equivalence to a marketed device.
• Documents: Cover letter, summary, device description, performance data.
• Timeline: Review typically takes 90 days.

PMA (Premarket Approval)

• Purpose: Required for Class III devices to prove safety and effectiveness.
• Documents: Device description, study results, labeling, manufacturing info.
• Timeline: Review can last up to 180 days or more.

De Novo

• Purpose: Establish new classifications for low- to moderate-risk devices.
• Documents: Device description, risk assessment, performance testing.
• Timeline: Usually 120-150 days.

IDE/IND (Investigational Device Exemption / Investigational New Drug)

• Purpose: Facilitate clinical studies for investigational devices or drugs.
• Documents: Study protocol, consent documents, preclinical results.
• Timeline: 30-day review period.

NDA/ANDA (New Drug Application / Abbreviated New Drug Application)

• Purpose: Approvals for new drugs (NDA) or generics (ANDA).
• Documents: Form FDA 356h, quality data, clinical data, labeling.
• Timeline: 6-10 months for standard review.

BLA (Biologics License Application)

• Purpose: Approval for biologic products like vaccines.
• Documents: Administrative details, product info, clinical data.
• Timeline: 10-12 months.

European Union (CE Mark)

• Purpose: Certify compliance with EU regulations for medical devices.
• Documents: Technical file, risk management report, clinical evaluation.
• Timeline: Typically 6-12 months.

MFDS/Korea

• Purpose: Approval of medical devices and drugs in Korea.
• Documents: Device master file, clinical data, application form.
• Timeline: 4-12 months based on product category.

PMDA/Japan

• Purpose: Approval of pharmaceuticals and medical devices.
• Documents: Common Technical Document, clinical data, application forms.
• Timeline: 1-2 years, with some conditional approvals.

NMPA/China

• Purpose: Approval of drugs and devices in China.
• Documents: Registration form, technical dossier, local trial data.
• Timeline: 12-24 months, with expedited options.

Key Considerations

• Harmonization: Use CTD for drugs and STED for devices.
• Translation: Comply with local language requirements.
• Clinical Trials: Local study requirements vary (e.g., NMPA requires local trials).
• Expedited Pathways: Utilize programs like FDA’s Breakthrough Devices and NMPA’s priority review.

Preparation and adherence to regulatory standards are crucial for timely approvals and market access.