Regulatory Affairs
Our Team offers extensive regulatory affairs knowledge and expertise to support you through all stages of your drug development, in an efficient and pragmatic manner.
We can support you to put together a regulatory strategy document to determine your pathway forward. Plans can be validated by preparing briefing documents and support through Regulatory Agency meetings. We can manage development programs from the very early stages of development through to the submission of a Marketing Authorisation Application.
Submission of Marketing Authorisation Applications
Marketing Authorisation Applications are developed and coordinated by Regulatory Experts and supported by CMC, non-clinical, clinical and medical writing experts on an as-needed basis.
Our international regulatory affairs professionals are highly experienced in the coordination, preparation and submissions to any Regulatory Authority.
We provide Consultancy and Services for:
- Preparation and Management of Applications for Centralised Authorisation Procedures (CAP), Mutual Recognition (MRP), Decentralised procedures (DCP) and National Procedures (NAP)
- Variation, planning, submission and Management
- High-qualityty translations of the Summaries of Product Characteristics, Labelling and Patient Leaflet to the local language
- Due Diligence
- Medical and Regulatory writing (e.g. Protocols, Investigator’s Brochure, Investigational Medicinal Products Dossiers, CMC, Non-Clinical and Clinical Overviews and Summaries, ISE and ISS)
- In-house training, mentoring and departmental reviews
- Regulatory compliance
- Clinical trial applications
- Orphan drug designations
- Paediatric investigational plans
- Regulatory strategy
- Scientific advice
- International via a network of local consultants
Application (MAA) & Clinical Trial Applications (CTA)
Highly experienced Regulatory Affairs professionals coordinate a network of local experts to submit local clinical trials and ethics committee applications to minimize issues related to local nuances and language barriers and maximise efficiency.
For clinical trials, we give advisory and prepare:
- Investigator Brochures (IBs)
- Investigational Medicinal Product Dossier (IMPDs)
- All other elements of clinical trial submissions
Regulatory Advice
Our experts provide information, insight, update and training on Pharmaceutical legislation (Human Medicines, Veterinary Medicines, Medical Devices).
MDR 2017/745 compliance
Medical device regulation (MDR) 2017/745 is the latest set of regulations that govern the clinical investigation, production, and distribution of medical devices in Europe.
This regulation applies to medical devices that come into direct contact with humans (e.g., bandages, catheters, implants).
Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
We provide support, guidance, and services with respect to conformity of assessment procedures, clinical investigations, clinical evaluation, vigilance and market surveillance according to the Medical Device Regulation (EU) 2017/745.
A strong network of Partners
With our network of Partners and our extensive expertise, we support you to adopt the right solutions for all stages of your drug development and managed services model that fits your needs in the best way.
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