Our Innovative Process to Tackling Regulatory Challenges

Our process is designed to simplify complex regulatory pathways while enhancing efficiency, compliance, and success. By integrating expertise and innovation, we deliver:

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, preparation, and submission are critical processes for ensuring compliance with regulatory authorities during product development and commercialization. Below is a detailed overview of these processes across key pathways and regions.

FDA Regulatory Pathways

Q Submission (Pre-Submission) to FDA

• Purpose: Allows sponsors to obtain FDA feedback during early product development stages.
• Documents:
  • Cover letter
  • Background information
  • Device description
  • Specific questions for FDA
  • Summary of proposed testing or clinical plan
• Timeline: Submit at least 60-90 days before desired meeting date.

510(k)

• Purpose: Demonstrates substantial equivalence to a legally marketed predicate device.
• Documents:
  • Cover letter
  • 510(k) summary
  • Device description
  • Predicate comparison
  • Performance testing data (bench, animal, clinical)
  • Labeling and instructions for use
  • Declaration of conformity with standards
• Timeline: FDA review typically takes 90 days.

PMA (Premarket Approval)

• Purpose: Required for Class III devices showing safety and effectiveness.
• Documents:
  • Administrative information
  • Device description and intended use
  • Non-clinical and clinical study results
  • Labeling
  • Manufacturing information
  • Financial disclosure
• Timeline: FDA review can take up to 180 days or longer.

De Novo

• Purpose: Establishes a new device classification for low- to moderate-risk devices without predicates.
• Documents:
  • Administrative details
  • Comprehensive description of the device and use
  • Risk assessment and mitigation strategies
  • Performance testing and clinical evidence
  • Proposed classification and rationale
• Timeline: Typically 120-150 days.

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

• Purpose: Permits clinical studies of investigational devices or drugs.
• Documents:
  • Study protocol
  • Investigator's brochure
  • Informed consent documents
  • Preclinical testing results
  • Risk analysis
  • FDA Form 1571 (IND) or 1572 (IDE)
• Timeline: 30-day review period by FDA.

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

• Purpose: Approval to market new drugs (NDA) or generic equivalents (ANDA).
• Documents:
  • Form FDA 356h
  • Quality (CMC) data
  • Non-clinical and clinical data (NDA)
  • Bioequivalence studies (ANDA)
  • Labeling
• Timeline: 6-10 months for standard review.

BLA (Biologics License Application)

• Purpose: Approval for biologic products such as vaccines, blood products, and gene therapy.
• Documents:
  • Administrative details (Form FDA 356h)
  • Product, manufacturing, and facility information
  • Preclinical and clinical data
  • Labeling
• Timeline: 10-12 months.

European Union (CE Mark)

• Purpose: Certifies conformity to EU regulations for medical devices and IVDs.
• Documents:
  • Technical file including device description, intended use, and design verification
  • Risk management report (ISO 14971)
  • Clinical evaluation report (MDR)
  • Post-market surveillance plan
  • Declaration of Conformity
• Notified Body Role: Review and certification.
• Timeline: Varies, often 6-12 months depending on class and complexity.

MFDS/Korea

• Purpose: Approval of medical devices and drugs for the Korean market.
• Documents:
  • Device master file (DMF) or Drug Master File (KDMF)
  • Technical documents (STED)
  • Clinical data (if applicable)
  • Quality assurance certification (KGMP)
  • Application form and labeling
• Timeline: 4-12 months depending on the product category.

PMDA/Japan

• Purpose: Approval of pharmaceuticals and medical devices.
• Documents:
  • Common Technical Document (CTD) for drugs
  • Preclinical and clinical data
  • GCP and GMP compliance reports
  • Risk management plan
  • Application forms
• Timeline: 1-2 years, with conditional approvals possible for some devices.

NMPA/China

• Purpose: Approval of drugs, devices, and biologics for the Chinese market.
• Documents:
  • Device or drug registration form
  • Technical dossier
  • Local clinical trial data (unless exempt)
  • Chinese labeling and instructions
  • CMC documentation
• Timeline: 12-24 months, with pilot programs for expedited pathways.

Key Considerations Across Regions

1. Harmonization: Use of CTD format for drugs and STED for devices where applicable.
2. Translation: Ensure compliance with local language requirements.
3. Clinical Trials: Varying requirements for local studies (e.g., NMPA mandates local clinical trials for most products).
4. Expedited Pathways: Utilize mechanisms like FDA’s Breakthrough Devices Program, PMDA’s Sakigake designation, and NMPA’s priority review.

Preparation and adherence to regulatory requirements significantly impact the approval timelines and market access strategies.