What you need to know to submit Study Data to FDA
In the current challenging and competitive pharmaceutical and life science industries, it is imperative that companies overcome any obstacles they encounter as quickly as possible in a manner that is effective, conforms with quality and compliance regulations and does not impact product safety.
At PharmaLex, we have developed a Technical Helpdesk service to allow our clients quick and easy access to regulatory compliance information and support provided by our team of experts. The support can be provided via email, phone or an on site visit.
How does the Helpdesk Work?
For greater flexibility the help desk operates using pre-purchased credits. Once PharmaLex receives your technical query via email or phone, we will agree the number of credits that will be used to provide you with a written response and a timeline for delivery. For each Technical Query, PharmaLex will respond with a comprehensive documented response in compliance with current legislation and best practice standards.
What types of Queries can be covered by our Helpdesk?
The Helpdesk can to provide answers to a wide range of technical queries covering all areas including but not limited to;
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Good Pharmacovigilance Practice (GVP)
- Good Clinical Practices (GLP)
- Medical Device Regulations
- Investigational Medicinal Products (IMP)
- Marketing Authorisation Holder (MAH) compliance
- Promotion and Advertising
- Current Best Practice – various topics
- Interpretation of Legislation e.g. FMD
- Opinion on specific scenarios
- Review of Investigation Reports, Draft QTAs, etc.
- Batch specific quality queries
- Quality Risk Management (QMR)
- Computer System Validation (CSV)
What are the Benefits to the Technical Helpdesk?
- Ready access to a team of international consultants, including several former EU and US Regulators, with expertise across the entire product lifecycle
- Input from SMEs as required
- Independent assessment and expertise to support client’s own expertise
- Leverage specific expertise and consultant team knowledge of current best practice and Regulatory expectations.
- Having pre purchased credits allows for a faster response time (as the PO is already in place) with solutions provided.
- PharmaLex will provide the estimated consultancy hours required to the client when the initial query is received, and the actual consultancy hours will be invoiced when query is resolved allowing for complete transparency for the client.
- Service can be used by different departments within the same company
For more information on our Technical Helpdesk, or any other services that PharmaLex provide, why not get in touch by connecting with us on +353 1 846 4742 or email us at contactirl@pharmalex.com.
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