Consultant Experience

Offering at least 15-30 years of regulatory experience that each consultant has, FDAlink FDA consultants have been able to partner with many international companies in the field of medical devices, pharmaceuticals, cosmetics, food and electronic products to provide the most thorough regulatory compliance consulting.

Medical Devices, Radiation-emitting Devices
FDAlink consultants have the finest experience in regulatory affairs. At numerous international medical device companies, our consultants were:

• Responsible for all quality systems and regulatory and clinical issues that affect the product, and facility related to government regulations, standards, guidelines or procedures. Active participation on regulatory/quality local and national organizations.
• Responsible for worldwide compliance and product submission approvals and certifications. Interact with most governmental regulatory agencies involved with the regulation of the healthcare industry. Handle FDA involvements and deal effectively with international trade organizations regarding the emerging EC directives and norms for healthcare requirements in USA and Europe in the 1990¡¯s.

Pharmaceuticals, Biologics, Biotechnology, OTC drugs (Cosmetics)
Through our experience with international pharmaceutical companies, we have performed:

• Establishing Quality Assurance System and regulatory departments for radiopharmaceutical and pharmaceutical companies.
• Preparing for regulatory submissions like IND, NDA, PMA, BLA or CMC and other support documents
• Reviews of compliance document and records
• Quality Systems due diligence for ISO certification and FDA PAI.
• Designing clinical trials

Foods / Dietary Supplements
Our consultants understand the scientific reasoning behind various FDA and USDA regulations, and apply it to efficient and expedient regulatory compliance. We can do this right because we have Food Technologists just like FDA and USDA does. At various large companies like McCormick Company, our consultants have performed:

• Managing the Quality Assurance Department
• Participating as the authority for USDA/FDA labeling
• Handling all USDA, FDA, FTC and BATF interactions for companies
• Directing all printed and television label claim substantiations
• Developing standardized, government approved programs
• Developing a regulatory database that contains a listing of 2600 regulatory items and their USDA/FTC Code of Federal Regulations (CFR) reference and for the FDA, both CFR and Compliance Policy Guide
• Managing Food Safety issues, advertising claims requirements, ingredient and additive regulations worldwide.