From the date this package is offered (August 2023), Delphic HSE will be offering three distinct services that will help guide all clients through the MoCRA requirements using an integrated three step model:

Step 1

Planning for product compliance
(MoCRA Plan)

Step 2

Implementation of product compliance
(MoCRA Ready)

Step 3

Maintaining product compliance
(MoCRA Go)

Step 1: Planning for product compliance

Understanding your supply chains

MoCRA introduces a range of new roles, responsibilities and obligations for those across the supply chain, making the understanding of, and preparation for, MoCRA a key challenge in securing the ongoing safety and compliance of Cosmetic Products that are marketed in the USA. Upon joining Delphic HSEs full 3-step MoCRA Service Package, the first step will be the completion of Qualification Questionnaires and Data Gathering Tools to help ensure we know as much as possible and make the process as smooth and efficient as possible. Following the completion of these, you will have access to expert consultation with one of our in-house Regulatory Experts to produce a customized ‘MoCRA Compliance Plan’. This will be a roadmap of future work, including; confirming the status of the Responsible Person, identifying the Cosmetic Products that require Listing, Facilities that require Registration and the key timelines involved.

With MoCRA Plan, Delphic HSE will provide you with regulatory access and meetings with your Regulatory Expert to help ensure progress to hit key dates and deadlines.

Key Features of MoCRA Plan

Access to our ‘MoCRA Plan’ pre-qualification questionnaires and guidance
Dedicated consultation time with Regulatory Experts to produce a ‘MoCRA Compliance Plan’ that includes:
- Identify who is the Responsible Person
- Understand the obligations for yourself, the RP and any facilities
- Identify the Products to be listed
- Identify the Facilities to be registered
- Ongoing support and consultation with your Regulatory Expert
- Determine the level of resource, and costs, required to meet the required product volume, type, priorities, timelines and expectations.
Enable you to appoint Delphic HSE as your US Agent
Introduction to key entities within the supply chain to ensure we have suitable contact, communication and confidentiality protocols in place ready for Step 2 (MoCRA Ready)

To receive a formal MoCRA specific proposal which includes more detailed information and costs or if you have any further questions on MoCRA, please contact us.

Step 2: Implementation of product compliance

Implementation of Safety and Compliance reviews across your product range to ensure they are – MoCRA Ready

Guided by your MoCRA Compliance Plan, Delphic HSE will proceed to Step 2 and deliver your MoCRA Ready Package. The purpose of MoCRA Ready is to ensure that all products we review are safe and compliant before being formally registered with the FDA. This will include a range of regulatory and toxicological reviews, with regular and open dialogue with both the client and the suppliers (if required). The following provides a summary of what is included within the MoCRA Ready service package.

MoCRA Ready service package

MoCRA Ready

Assistance with and review of Facility Registration

Preliminary GMP Risk Analysis against requirements

Product Listing and registration once safety and compliance work streams are complete

Review of product label and claims

Review of existing Claims Substantiation if required and requested

Safety Substantiation to ensure product is both safe and compliant

Building a product data repository and ensuring access to these records is created and accessible

Identification of Ingredients that are a ‘High Risk’ for future changes documented by MoCRA (i.e. Fragrance Allergens, PFAS, Talc)

Delphic HSE will consider the MoCRA Ready service package complete when the required products are confirmed as safe, compliant and fully registered with the US FDA. Delphic HSE will provide regular updates on progress and completion of all pre-determined milestones including the final registration.

Once MoCRA Ready is complete, Delphic HSE will proceed to activate the MoCRA Go service package to ensure products remain safe and compliant throughout their US market lifecycle and our client can maintain suitable communication with consumers and authorities (with regards to product compliance).

To receive a formal MoCRA specific proposal which includes more detailed information and costs or if you have any further questions on MoCRA, please contact us.

Step 3: Maintaining product compliance

When Delphic HSE has formally registered the products with the FDA, the client partnership then moves to an ‘in-market’ surveillance relationship.

Whilst it is imperative that all cosmetic products launched to the US market are safe and fully compliant with the MoCRA regulation prior to product listing/registration, it is equally important that the products remain compliant throughout their lifecycle. As such it is the responsibility of the Responsible Person to ensure that compliance is maintained. Delphic HSE has created MoCRA Go, as a service support package to perform all the required ‘in-market’ requirements on behalf of the Responsible Person.

The obligations and roles of the Responsible Person under MoCRA will be identified as part of MoCRA Plan, however, Delphic HSE will support through the process: For Overseas companies which do not have a US entity as the RP, Delphic HSE will identify the steps necessary for ensuring compliance with MoCRA and support as the US Agent.

MoCRA Go service package

MoCRA Go
Service	Description
Responsible Person Silent Partner and / US Agent Support	Once MoCRA comes into enactment, Delphic HSE will launch the MoCRA Go service where Delphic HSE will provide ongoing support to the Responsible Person and the Facility(ies) within their supply chain.
Market Surveillance and Due Diligence	Maintenance of Product Records
	Serious Adverse Event
	Causality Assessment if required to support Adverse Effect
	Ongoing state and federal regulatory Monitoring
	Impact Analysis following any pending regulatory changes/updates including remedial actions
	Product Profiling and maintenance
	Product Recall support
	Product Sampling (Optional – Additional service at request of RP)

To receive a formal MoCRA specific proposal which includes more detailed information and costs or if you have any further questions on MoCRA, please contact us.

Delphic HSE is delighted to announce our latest global expansion

We are honoured to welcome Delphic HSE Solutions LLC, located in the United States, into the Delphic Group.
3753 Howard Hughes Parkway, Suite 200 - 1277, Las Vegas.

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