for USA companies
Medical Devices
Cosmetics
Borderline Products
Electronic publishing
Helping American pharma companies
grow
their European business
Establishing a European presence is a big undertaking and requires expert advice and careful planning. Our regulatory team will guide you through the legal and regulatory minefield and ensure a clear path to market.
So what does this involve? Our work includes:
• Advise on importation of biological products from USA to Europe including assistance with logistics, product release, regulation and European law
• Regulatory support for pharmaceutical development services including manufacturing, analytical chemistry, formulation development, microbiology, biotechnology and clinical research
• Development, preparation and assembly of complete dossiers for
Europe and USA
• Preparation of responses to regulatory authorities, comment letters, and assessment reports
• Representation to regulatory agencies and meeting planning
• Regulatory submission critique including recommendations to help improve review of applications by regulatory authorities
• Assistance in responding to compliance issues
• Accurate labelling
• Due diligence on product regulatory packages
• Dossier submission to regulatory authorities
Practical advice and help
We can provide advice on product formulation, indications and dosage instructions. We'll resolve issues around products with specific difficulties. For novel forms of therapy, we'll represent your company. We'll meet with regulatory agencies to discuss key concerns and report back on best course of action.
Regulatory due diligence
Regulatory due diligence can be undertaken for potential licensing opportunities. Our team will help you with chemistry and manufacturing as well as preclinical and clinical assignments.
Helping to resolve regulatory questions
Regulatory consultants act as a linchpin between many groups of people. From drug development teams through to marketing and legal affairs, as well as external health authorities.
This holistic view of the drug development process means we're well equipped to respond to questions raised by regulatory agencies. We'll review questions raised and examine all submitted data. We will work with agency on your behalf to achieve a successful outcome.
Document preparation
Work begins as soon as a new drug is discovered and continues long after product reaches pharmacy shelves. Stringent testing requirements have to be met and include accurate and detailed information along with convincing analysis and results.
Before documentation is submitted, it's down to regulatory affairs to ensure the right tests have been done at the right times - and with the correct interpretation of results.
Even when a licence to sell a new treatment has been granted, work doesn't end there. It's important to ensure a medicine's packaging is accurate and informs patient about benefits and potential drawbacks.
We'll manage implementation of responsible labelling and packaging to ensure new treatments are effective, have minimal risks and quickly reach your market.
Good labelling can safeguard against drug misuse and prevent dangerous side effects. Accurate labelling can be as much a lifesaver as the drug itself.
We'll prepare the following documents on behalf of our clients:
• Preparation of applications for clinical trial authorisation to Competent Authorities and Ethics Committees
• Mutual Recognition response documents
• Briefing documents for pre-NDA or EMEA scientific meetings
• Expert reports: CTD pharmaceutical, preclinical or clinical overviews.
Helping you with electronic submissions
Since the 1st January 2009 the EMEA has recommended
electronic-only submissions with eCTD. This applies to both new and existing submission types. Rapporteurs and CHMP members will not receive paper copies.
From 1st July 2009, paper and other (non-eCTD) electronic formats will only be received by the EMEA as an exception. Rapporteurs
and CHMP members will not receive paper copies or other
electronic formats.
What can PDS do for you?
• We perform eCTD readiness assessments (for your company's
in-house working process and template review)
• We manage the entire product submission process from conception to retirement, tailored to your needs, for preparing, converting and/or updating documents for submission, within EU or USA
• We use a validated, proven eCTD software package for compilation of regulatory submissions and publishing
• We can convert your legacy documents and ensure their eCTD readiness and ICH compliance
Benefits include:
• Your products go to market faster
• Reduced costs/resources/time needed to plan, locate and assemble regulatory content
• Better coordination/collaboration by sharing a single,
central resource
• Web interface to view/review dossier as it is built
• Secure, fully compliant and validated
