In a highly regulated and competitive market, launching a cosmetic or biocidal product requires more than just an innovative formula. It involves navigating complex legal frameworks, ensuring technical documentation is accurate, and meeting strict compliance standards. That is where regulatory consultancy services become essential.
At SHAPYPRO, we specialize in helping companies develop, validate, and market safe and compliant products, offering personalized guidance at every step of the process.
What Is Regulatory Consultancy?
Regulatory consultancy refers to professional support that helps businesses comply with applicable legislation and technical standards when developing and marketing products. In the context of cosmetics, disinfectants, or biocidal products, it includes:
- Regulatory strategy design.
- Preparation and review of product documentation.
- Labeling and claims assessment.
- Safety data compilation.
- Market authorization and notifications.
- Ongoing compliance monitoring.
The aim is to minimize legal risks, reduce time to market, and guarantee that the product meets both consumer and regulatory expectations.
Why Is Regulatory Consultancy Essential?
- Ever-Changing Legislation
European regulations such as Regulation (EC) No 1223/2009 for cosmetics or Regulation (EU) No 528/2012 for biocides are extensive and regularly updated. A consultancy service helps companies stay up to date with these changes and interpret the legal implications.
- Regulatory Risk Management
Non-compliance can result in:
- Product withdrawal.
- Fines or penalties.
- Damage to reputation.
- Restrictions on market access.
Regulatory experts can anticipate and manage these risks proactively.
- Faster Time-to-Market
A regulatory consultant helps streamline the launch process by:
- Advising on required safety and efficacy tests.
- Preparing Product Information Files (PIF).
- Managing CPNP and ECHA submissions.
This accelerates approvals and avoids unnecessary delays.
- Global Expansion
If a company wishes to export products outside the EU, regulatory consultancy becomes even more valuable. Each country has its own framework, and adapting a product to each market can be time-consuming and complex without expert support.
Regulatory Consultancy for Cosmetics
Under Regulation (EC) 1223/2009, cosmetic products must meet specific requirements before being placed on the market:
- Responsible Person (RP): Must be designated within the EU.
- Product Information File (PIF): Must include a safety assessment, formulation data, GMP evidence, and efficacy claims.
- Notification: Must be submitted to the CPNP platform.
- Labeling: Must comply with mandatory information (INCI, expiration date, warnings, etc.).
- Cosmetic Product Safety Report (CPSR): Must be completed and signed by a qualified safety assessor.
At SHAPYPRO, we offer tailored support to ensure full compliance in all of these areas.
Regulatory Consultancy for Biocides
Biocidal products are regulated under Regulation (EU) 528/2012 (BPR) and require:
- Inclusion of active substances in the Union list.
- Market authorization (either national or through EU processes).
- Submission of complete technical dossiers.
- Environmental and toxicological impact assessments.
- Labeling that meets BPR-specific requirements.
Navigating the BPR process without expert help can significantly delay time-to-market.
SHAPYPRO supports manufacturers and importers by:
- Preparing documentation and evaluating efficacy data.
- Advising on test selection and data gap analysis.
- Facilitating communication with competent authorities.
Key Services Offered by SHAPYPRO
Regulatory Strategy Development
We help define the most efficient regulatory pathway, based on product type, formulation, claims, and target markets.
PIF and CPSR Compilation
We prepare comprehensive product dossiers and coordinate with qualified assessors.
Label Review and Compliance Checks
Our experts evaluate packaging, artwork, and claims to ensure alignment with EU requirements.
Regulatory Submissions and Notifications
We manage submissions to:
- CPNP for cosmetics.
- ECHA for biocides.
- National health agencies when applicable.
Post-Market Surveillance
Ongoing monitoring to ensure continued compliance, especially following regulatory updates.
Who Needs Regulatory Consultancy?
- Start-ups developing their first product line.
- Established brands entering new markets.
- Raw material suppliers aiming to support their clients with documentation.
- Private label manufacturers requiring full compliance support.
In short, any company that wants to focus on product development and marketing while ensuring that legal requirements are met.
Common Mistakes Without Regulatory Guidance
- Omitting required elements in the safety assessment.
- Misinterpreting claims that require clinical substantiation.
- Failing to submit timely notifications.
- Using restricted or banned substances.
Regulatory consultancy prevents these oversights and ensures a smoother, safer product journey.
Why Choose SHAPYPRO?
- Experience in cosmetics, biocides, and medical devices.
- Multidisciplinary team: chemists, microbiologists, and regulatory specialists.
- Accredited testing and technical support.
- Tailored consultancy and ongoing updates.
We understand how to bridge the gap between innovation and compliance. Our goal is to help you launch products with full regulatory confidence.
📩 Contact us to learn more about how we can support your regulatory strategy.