PDS offers a complete pharmaceutical regulatory affairs support service during pharmaceutical development to assist in the implementation of a global regulatory strategy. The role of PDS staff is to tell you the current standards for your development regulatory submissions, and what you need to do to meet them. We explain why you need to do what needs to be done, and help you to generate data which will successfully meet the requirements.
Our services include:
- Development, preparation, assembly and submission of complete electronic Common Technical Documentation (e-CTD) for marketing authorization applications (MAAs) in both Europe and the USA.
- Orphan drug designation/applications
- Conversion of paper or NEES documents into electronic dossiers using e-CTD (electronic Common Technical Document) software
- Preparation of responses to regulatory authorities, comment letters, and assessment reports
- Provision of support for scientific advice meetings, representation to regulatory agencies and meeting planning
- Preparation and submission of European clinical trial authorization (CTAs) and ethics committee applications
- Risk management plans
- Due diligence and data evaluations.
Pharmaceutical regulations impact on all areas of drug development, manufacture, control and supply, from the early stages of drug development, through to dossier submission, approval and marketing.
PDS pharmaceutical regulatory affairs consultants have the experience to take a broad view of the development process. This means we are well-equipped to tailor pivotal submission documentation to facilitate a company’s chances of achieving optimum product information. Post submission, PDS can assist the client in responding to questions raised by regulatory agencies. PDS will review all questions and examine submitted data and we will work with agencies on your behalf to ensure an optimum path to market.
In addition, PDS can prepare the following documents:
- Briefing documents for pre-New Drug Application (NDA) or European Medicines Agency (EMA) scientific meetings
- EU Centralised/Mutual Recognition/Decentralised response documents.
Resolving issues with a complex product
The pharmaceutical regulatory affairs environment is complex and we can help resolve issues around products with specific difficulties. For novel forms of therapy, we can represent your company. With PDS, you can be confident that our experienced pharmaceutical regulatory affairs consultants will meet with regulatory agencies to discuss key concerns and report back on the best course of action.
In addition to advising on pharmaceutical regulations, PDS also provides regulatory strategy advice on a range of other healthcare products including:
- Medical devices
- Drug device combinations
- Herbal medicines
- Homeopathic medicines
By reviewing and refining a product’s formulation, labelling and promotional material PDS experts can assist in determining the appropriate legal category of a borderline product, so that the commerical viability of the product is optimised.
PDS has compiled a number of applications to the Advisory Committee on Borderline Substances (ACBS).
Regulatory due diligence
Regulatory due diligence can be undertaken for potential licensing opportunities. Not only can we identify gaps in old dossiers, but we can arrange for, and manage the conduct of, additional studies to complete the dossier.