FDA registered, ISO 13485:2016 and 9001:2015 certified

FDA registered, ISO 13485:2016 and 9001:2015 certified

Other Services

New Product Development (NPD) Consultations

New Product Development (NPD) Consultations
Product Drawings & Prototyping

Product Drawings & Prototyping

Custom Coating Machine Building

Custom Coating Machine Building
Packaging & labeling

Packaging & labeling

Regulatory Consulting Services

Clinical Literature Scooping:

Clinical Literature & Data Research, Review & analyze, Patent searches, Report generation.

Process Validation & Verification:

Mechanical testing protocol generation with acceptance criteria based on published literature, Help with IQ, OQ, PQ for FDA compliance.

Packing/Shipping:

Help with validation of packaging and documentation.

Regulatory Strategy Development:

Help in formulating a comprehensive regulatory strategy tailored to the specific product and market. Provide guidance on applicable regulations, standards, and submission requirements, taking into account the product's classification, intended use, and target markets.

Quality Management Systems (QMS):

Help in establishing and implementing effective QMS frameworks in accordance with regulatory standards such as ISO 13485 or FDA Quality System Regulation (QSR). Provide guidance on documentation, risk management, post-market surveillance, and other quality-related aspects.

Clinical Evaluation and Testing:

Help in designing and executing clinical studies, performing literature reviews, and assessing clinical data to demonstrate safety and efficacy. Assist in developing clinical evaluation reports (CER) and provide guidance on applicable clinical trial regulations.

Regulatory Submissions:

Assist in preparing and reviewing regulatory submissions, such as premarket notifications (510(k)), premarket approval applications (PMA), investigational device exemptions (IDE), technical files, design dossiers, and product registrations for devices to be sold in the U.S. Ensure that the submissions are accurate, complete, and compliant with the relevant regulations.

US and International Market Access:

Provide guidance on expanding into international markets, including regulatory requirements, product registration, and conformity assessments. Assist in preparing dossiers for CE marking (Europe) or submissions to other regulatory bodies worldwide.

Regulatory Intelligence:

Stay updated with the latest changes in regulations, guidance documents, and industry trends. Provide clients with regulatory updates, interpret their impact on product compliance, and help in adapting strategies accordingly.

For any regulatory related support, including review, deficiency response, & compilation, Audit regulatory consulting services, contact us.

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