Our Services

FDA Compliance Services

• Guidance on meeting and maintaining FDA regulations.

• Assistance in preparing for FDA inspections and audits.

• Implementation of FDA-compliant quality systems.

Drug Registration Services

• Assistance with preparing and submitting drug registration applications.

• Guidance on regulatory submissions.

• Obtaining DUNS numbers.
  Read our article: Understanding Drug Listings and the FDA

Cosmetic Product Listing

• FDA Cosmetic Product Registration.

• Ingredient Declaration & Labeling Review.

• Compliance with Federal Regulations.

• Ongoing Support & Updates.

  Read our article: Navigating Cosmetic Labeling Compliance: Essential Guidlines for Manufacturers

  Read our article: Modernization of Cosmetic Regulation Act (MoCRA): A New Era in Cosmetic Safety

Cosmetic Facility Registration

• FDA Facility Registration: Assistance with registering your cosmetic manufacturing facility with the FDA under MOCRA and keeping details up-to-date.

• Compliance Consulting: Expert guidance on adhering to FDA regulations, including cGMP practices, product safety, and labeling requirements.

• Product Listings & Adverse Event Reporting: Support with FDA product listings and setting up systems for reporting serious adverse events.

• MOCRA Compliance Support: Ongoing updates on MOCRA regulations and tailored compliance training to ensure your business stays compliant.

  Read our article: Navigating Cosmetic Labeling Compliance: Essential Guidlines for Manufacturers

  Read our article: Modernization of Cosmetic Regulation Act (MoCRA): A New Era in Cosmetic Safety

Annual Reporting

• Preparation and submission of drug registration applications.

503B Registration & Reporting

• FDA 503B Facility Registration.

• Assistance with FDA Form 356h for outsourcing facilities.

• Drug Product Reporting and NDC assignment.

• Maintaining adverse event documentation.

Labeling & Packaging Compliance

• Assistance with meeting 503B FDA requirements for product labeling.

Regulatory Affairs Consulting

• Strategic advice and regulatory document review.

• Representation and communication with regulatory agencies.

Audits & Assessments

• Comprehensive cGLP and cGMP audits.

• Gap analysis and risk assessments.

FDA 483 Remediation

• Root cause analysis and CAPA development.

• Staff training and ongoing support for compliance.

Quality Management Systems (QMS)

• QMS development, SOP review, and training.

Validation Services

• Equipment, process, and system validation assistance.

Post-Market Surveillance

• Adverse event monitoring and product complaint management.

OTC Monograph Drug User Fee Program (OMUFA)

• Report compilation and timely submissions.
  Read our article: FDA Regulations for OTC Drugs

Export Certificates & CPPs

• Obtaining and renewing export certificates.

Labeling Review

• Ensuring product labels meet FDA requirements.
  Read our article: Understanding Label Review and the FDA

Annual Drug Establishment Registration

• NDC reservation, Labeler Codes, and annual registration updates.
  Read our article: Understanding Drug Listings and the FDA

SOPs (Standard Operating Procedures)

• SOP development, review, and training programs.

Compliance Training

• Customized cGMP training for regulatory compliance.

Documentation & Recordkeeping

• Assistance with compliant documentation systems.

ANDA & IND Applications

• Assistance with ANDA and IND application submissions.

• Support with bioequivalence, stability studies, and clinical trials.