• Drug master files
• Management advice on setting up new regulatory affairs departments
• Ad hoc regulatory consultancy
• In house regulatory support

Drug Master Files

Wainwright Associates has a highly skilled team of consultants able to advise on, review or prepare Drug Master Files in accordance with the relevant regulatory requirements for content and format.

Where suppliers are reluctant for the applicant to have access to the ‘restricted’ part of the DMF, very often they will allow it to be reviewed by an independent third party with no commercial interest in the product, under a Confidentiality Agreement. Wainwright Associates can undertake this role, in direct communication with the supplier so that reassurance can be given to the applicant as to the quality of the DMF, without revealing any of the sensitive information.

We can also prepare applications for Certificates of Suitability to the appropriate European Pharmacopoeia monograph.

Management Advice on setting up New Regulatory Affairs Departments

Advice can be provided to senior management teams on setting up a new Regulatory Affairs Department. This includes assistance with designing the infrastructure of the department, setting up the necessary templates and formats for reporting and creating an effective filing system. We can advise on the skills required of regulatory staff and, if required, assist with interviewing candidates. We are also able to act as ‘caretaker’, handling day-to-day regulatory activities until a permanent team can be employed.

Ad Hoc Regulatory Consultancy

Virtual companies or those with only a small regulatory affairs team might benefit from the Wainwright Associates ad hoc regulatory consultancy service. Effectively, under this arrangement, Wainwright Associates becomes part of the client’s own team, providing access to the skills of all our consultants and our bank of literature, guidelines and legislation. We can act as a foil for regulatory queries, provide an independent ‘second opinion’ on proposed regulatory strategies or review draft submissions prepared in house. This service also allows access to our network of local advisors.

In House Regulatory Support

Where a company has a short-term need for regulatory support in house, caused by a temporary peak in workload, or absence due to sickness or maternity leave, Wainwright Associates can provide an experienced regulatory consultant to cover for the routine regulatory maintenance work. Depending on the location of the company and the nature of the work, this can either be based in the client’s own premises or at our own offices in Buckinghamshire, or a combination of both.