Wainwright Associates Ltd - Pharmaceutical Regulatory Affairs - Pharmaceutical Consultants - Pharmaceutical Product Development

We have a specialist pharmaceutical regulatory affairs team of consultants who offer advice to you in all areas of regulatory affairs. Our team of consultants are specialist in healthcare products, medicines and medical devices.

Our expert pharmaceutical regulatory affairs team can help you with:

• Regulatory planning for a future submission
• Advice on regulatory requirements worldwide
• Writing or reviewing a dossier
• Troubleshooting an unsuccessful submission or conducting an appeal
• Liaison with the regulatory authorities
• Maintenance of regulatory approvals throughout their life cycle

We provide a pharmaceutical consultants' service to help and support, as well as provide technical and administrative advice. Our pharmaceutical consultants' service is flexible, professional and offered globally in over 60 countries worldwide. Our pharmaceutical consultants' service is fully confidential. As an independent organisation, there will be no conflict of interest.

From the very early stages of your product development, our pharmaceutical product development consultants can help you on your way to a regulatory pathway to lead to a smooth and timely regulatory approval.

We have a team of pharmaceutical product development consultants to help with your global regulatory intelligence, strategic regulatory planning and assessment of scientific data.

The scientific data can be assessed by discipline experts to identify and resolve any deficiencies and plan future studies. Formal strategic development plans can be drawn up and implemented. Furthermore, we can provide global regulatory intelligence regarding local requirements for market entry in most of the major territories of the world.

We offer professional medical device services on a consultation basis including medical devices and in vitro diagnostics. We have a highly qualified team which includes biologists, pharmacists, chemists and medical practitioners.

Our medical device services are designed to provide assistance on product development, preclinical and clinical research, regulatory affairs and quality assurance.

Our assessment of scientific data service facilitates regulatory approvals by highlighting deficiencies so recommendations can be made to resolve them.

Our assessment of scientific data is ultimately aimed at producing a technical assessment report that is invaluable for management tools in many situations.

We can provide a professional strategic regulatory planning service that will ensure you take full advantage of the best route to market and benefit from all the incentives that you will can.

Our strategic regulatory planning service is aimed at helping your medical product or device into a new market but taking into account national legislation, relevant guidelines and current medical practice in the interested territories. This information can be difficult to obtain and our strategic regulatory planning service is designed specifically to help with this area.