SUS Regulatory Ltd provides expertise covering business strategies as well as regulatory, clinical, operations, and safety considerations. Our diverse team of consultants can assist you in the development of pharmaceuticals, biologics, medical devices, combination products, consumer health products, Nutritional and cosmetics.
Highly seasoned professionals comprise our consulting team, and offer exceptional academic credentials and solid industry experience. The team is integrated cross-functionally with all groups within SUS Regulatory, enabling them to draw on an exceptional depth and breadth of resources, enabling them to produce best-in-class recommendations for the most complex challenges.
Consulting Services
We provide a wide range of services for regulatory projects such as registration of NCEs via centralised, decentralised, mutual recognition and national procedures, preparation of Orphan Drug Applications, in-licensing and out-licensing, training regulatory staff, labelling and compliance.
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Consulting Services:
- Strategic consulting to minimize risk and maximize return on investment
- Global project management
- Due diligence
- Market intelligence
- Interpretation of agency rulings, policies, and guidelines
- SOP review
- Global Regulatory Operations
- Electronic Submissions Publishing
- Regulatory Consulting
- Labelling Services
- License Transfers
- Reformulation strategies, particularly on large projects with short timelines
- Strategies to maximize labelling claims
- Guidance on import/export procedures
- Preparation of CCDS that contain all the necessary information:
- Approved indications
- Dosing requirements
- Methods of administration
- Concerns of special patient populations
- Packaging and storage requirements and limitations
- Incompatibilities and pharmacological properties
- Safety information
Regulatory onsite
Stakeholders interests and registration strategies are assessed while local legal regulations and quality are considered throughout the product development process.
Regulatory offsite
SUS Regulatory provides dependable global regulatory affairs and services whereby submissions are managed scrupulously whilst maintaining an efficient approval rate.
Project management
With the constant amendments to regulations, SUS Regulatory has the versatility that allows all types of submissions to be handled internationally, with the re-assurance that a group of well-trained, experienced and qualified scientific specialists will be there every step of the way.
Our team provides:
- Expertise in small molecules, biologics, vaccines, medical devices, combination products, consumer health products, and cosmetics
- Strong relationships with regulatory authorities in the US, EU, and ROW
- Experience with hundreds of successful submissions and approvals throughout the world
- Large network of key opinion leaders in a vast array of indications and geographic regions
- Product life-cycle management
- Post-marketing support
- Preparation of, and assistance with, submission of amendments, supplements, and variations to marketing authorizations
- Review of changes to advertising and promotional materials
- Renewal of licenses for Rest of World (ROW) countries
- Help with EU renewal procedures (CP/NA/MRP/DCP/RUP) and full support for all steps from preparing the application form to compiling the documentation to granting the renewal
- Provide responses within stipulated timelines on queries/deficiencies raised by health authorities and customers
