Our Services

Regulatory Affaris Services FDA cosmetics industry

Our Services

Raw Material/Ingredient Assessment

Raw material and ingredient assessment for cosmetics and drugs and beyond

 

Are you developing or considering the use of new raw material or cosmetic/drug ingredient?  Does it have the appropriate regulatory compliance?  Is it safe for its intended use?   LAK3 Consulting has extensive regulatory and toxicology experience to help you navigate the regulations for cosmetics and pharmaceuticals.  We also have knowledge of ingredient applications covered by the Toxic Substance and Control Act (TSCA), such as use in pet shampoos and industrial applications.

 

We are experienced in conducting comprehensive reviews of substances and their residual contaminants to determine if they are safe for their intended use.  We can also provide guidance on cutoff limits of residual contaminants and solvents for the US and other countries.

Raw Material/Ingredient Assessment
US FDA OTC Topical Drug Compliance

US FDA OTC Topical Drug Compliance

Do you manufacture or supply ingredients used in US FDA Over The Counter (OTC) Topical Drugs?  We have extensive experience in active ingredients, inactive ingredients (excipients), and formulations of OTC topical monograph drugs such as sunscreens, hand sanitizers, isopropyl alcohol, etc.  We can help with:

  • Drug Establishment registration, including United States Agent for foreign registrant

  • Drug Listing

  • Safety assessment of novel inactive ingredients

  • Drug Facts labeling and labeling claims review

  • OTC Monograph compliance

  • Updates and strategic planning for OTC Monograph Reform

 

Green Chemistry/Sustainable Ingredients

Are you considering the use of a new green chemistry/sustainable ingredient in your products?  Or are you a small start-up business developing new and innovative ingredients using green chemistry?

 

It can be expensive and time-consuming to conduct a global new chemical registration program.  We can help by advising you on the best regulatory path forward, especially if your resources are limited. 

Green Chemistry/Sustainable Ingredients
California Proposition 65 Safe Harbor Risk Assessments

California Proposition 65 Safe Harbor Risk Assessments

Do you sell formulated products to consumers in California, such as cosmetics or pet shampoos?  If so, then a California Proposition 65 safe harbor risk assessment may help you determine whether you need to provide a Proposition 65 warning on your product.

 

We assess the ingredients and residual contaminants in your formula and packaging and determine whether potential human exposure would exceed the Proposition 65 “safe harbor” levels.

Due Diligence Regulatory/Compliance Assessment

Are you considering purchase of a new company or product line?  We can conduct a regulatory/compliance assessment using your due diligence checklist or our own.  We have experience accessing data rooms for due diligence projects and can provide comprehensive reports of our regulatory/compliance findings in a timely manner.

 

What about post-due diligence activities?  If you have recently acquired a new company or product line, then it is important to conduct a regulatory/compliance assessment and obtain guidance on how to update or maintain compliance, especially if this is a new regulatory area for your company.  For example, we can assess US Food and Drug Administration (FDA) and State compliance for cosmetics and OTC drug products.  We also offer this service for active or inactive ingredients used to manufacture cosmetics and drug products.

 Due Diligence Regulatory/Compliance Assessment

Address

LAK3 Consulting LLC

9 S Greenwood Avenue

Unit 669

Hopewell, NJ 08525, USA

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