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Regulatory Services

Regulatory Services | SciKonnect

SciKonnect Regulatory Services

Trusted Regulatory Guidance for Pharma, Biopharma & MedTech Companies Worldwide

About Our Regulatory Services

SciKonnect provides comprehensive regulatory consulting services to help pharmaceutical, biopharmaceutical, and MedTech companies establish robust and compliant pathways to the U.S. market. Our team brings deep FDA experience, ensuring your product development strategy aligns with evolving regulatory expectations.

 

We focus on proactive regulatory planning—helping you minimize delays, mitigate risk, and maintain long-term market access. By anticipating FDA audit needs, we help clients avoid costly remediation and foster a culture of high-quality compliance.

Scope of Services

  • > End-to-end FDA regulatory guidance and compliance consulting.
  • > CMC (Chemistry, Manufacturing & Controls) strategy for drug development and lifecycle management of APIs and finished dosage forms (oral and injectables).
  • > Support for FDA interactions including pre-IND, EOP2, and pre-NDA meetings; NDA/ANDA data evaluation for market approval.
  • > CMC change management and post-approval lifecycle support.
  • > Guidance to make development and operations more efficient and cost-effective within regulatory frameworks.
  • > Preparation for FDA inspections, evaluation of Form 483 observations, and support for GMP compliance.
  • > Device regulatory consulting, including classification and regulatory pathway assessment (510(k), De Novo, PMA, IDE, etc.).
  • > Preclinical testing strategy for performance, biocompatibility, and chemical characterization assessments.
  • > Preparation and review of Pre-Sub and Q-Submissions (question framing, dossier review, and slide preparation).
  • > Independent review of scientific and test data for validity and integrity prior to submission.
  • > Training workshops for startup teams on FDA expectations, submission best practices, and compliance readiness.

Our Expertise

Our advisors have extensive experience working with or within the U.S. FDA across drug, biologic, and medical device divisions. With backgrounds in regulatory science, chemistry, and materials evaluation, they bring deep insight into the FDA’s decision-making processes.

Expertise Highlights:
  • > 20+ years of regulatory experience in CMC strategy and FDA compliance.
  • > Hands-on experience evaluating IND, NDA, ANDA, 510(k), PMA, and IDE submissions.
  • > Expertise in polymer materials, biocompatibility, and performance testing for medical devices.
  • > In-depth understanding of ASTM and ISO standards development for polymer and device testing.
  • > Direct experience conducting and preparing for FDA inspections, including international sites.
  • > Proven track record of regulatory strategy development for both early-stage and established companies.

Why Choose SciKonnect?

  • > Unparalleled insider knowledge of FDA regulatory pathways.
  • > Integrated consulting across drugs, biologics, and medical devices.
  • > Focus on CMC excellence and cost-effective regulatory operations.
  • > Hands-on mentorship for startups and early-stage innovators.
  • > Commitment to scientific integrity, data reliability, and compliance readiness.

Contact Us

Interested in regulatory guidance or FDA submission support?
Email: info@scikonnect.com
WhatsApp: +91 7988722897

 

Please note: Direct queries to individual consultants will not be entertained. All communications must go through SciKonnect official channels.

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