Quality Support for New Product Development

Technical Support for New and Existing Products

At Bio-Tech Solutions, we go beyond manufacturing. We offer comprehensive technical support to our clients throughout the entire product lifecycle, from initial concept to market launch and beyond. Our team of experts provides guidance and assistance in navigating the complex regulatory landscape for medical devices, cosmetic products, and pet care products.

Our commitment to technical support ensures that our clients can bring safe, effective, and compliant products to market with confidence. Our Technical Team will support our customers in maintaining product compliance throughout its lifecycle.

Support for New Product Development

We understand the challenges of bringing new products to market. Our technical support services are designed to streamline the development process and ensure compliance with relevant regulations and quality standards.

Expertise in Regulations and Quality Standards

Our team possesses in-depth knowledge of the regulations and quality standards governing medical devices, cosmetic products, and pet care products. We provide expert guidance on:

Medical Devices: Compliance with ISO 13485, Medical Device Directives (MDD), and
Medical Device Regulations (MDR).
Cosmetic Products: Compliance with the EU Cosmetics Regulation (EC) No 1223/2009
and the UK Cosmetics Regulation 2020.
Pet Care Products: Compliance with relevant regulations and safety standards.

Laboratory Development and Trials

We offer laboratory development and trial services at competitive rates to support the development and validation of your products. Our facilities and expertise enable us to assist with:

Formulation development and optimization

Stability testing
Microbiological testing
Compatibility testing

Areas of Support

Our technical support services cover a wide range of areas, including:

Medical Device File Preparation: Compilation of technical documentation required for medical device registration.
Cosmetic Product Information File (PIF) Development: Development of the comprehensive PIF required for cosmetic products.
Product Risk Assessments: Conducting risk assessments in accordance with ISO 14971 for medical devices and HACCP for relevant products.
Regulatory Compliance Assistance: Guidance and support in meeting all relevant regulatory requirements.

Ongoing Support for Existing Products

We continue to provide technical support for existing products, including:

Change Management: Assistance with managing product changes and ensuring continued compliance.
Supplier Qualification: Evaluation and qualification of suppliers to ensure quality and compliance.
Troubleshooting and Problem Solving: Technical expertise to address any quality or compliance issues.