Regulatory Consulting for Pharma & Biotech
Aptiv Solutions has significant experience in helping clients understand the regulatory requirements for the development of medicinal products covering everything from strategic development planning to market registration.
Our regulatory consulting services team will provide representation in front of Regulatory Agencies, author regulatory documents, and manage the submission process to regulatory approval:
Implementation of an appropriate regulatory strategy is critical to efficient drug development and the successful approval of products. Aptiv Solutions provides expert consultation for regulatory strategy development planning, agency advice and regulatory submission strategy.
In addition to strategic capability in the major markets, our regulatory team has practical experience in a wide range of procedures and products:
- Clinical Trial and Marketing authorization applications in Europe, US/Canada and ROW
- Due diligence & data evaluations
- Orphan drug designations
- Pediatric investigational plans and pediatric development strategies
- Japanese regulatory strategy & advice
- Medical devices & drug-device combination products
- Small molecules & biologics
- Advanced therapy medicinal products
- Established drugs and generic products
Obtaining the correct agency advice is a critical part of the product development and market approval process. Our regulatory experts have significant experience in interacting with regulatory agencies in North America, Europe, Japan and ROW.
Using an efficient process to identify the critical issues to be discussed, and supported by preclinical, CMC and medical experts, we will produce and submit comprehensive briefing documents to the regulatory agencies to guide appropriate discussion. Our regulatory team has experience in all types of agency meetings:
- Pre-IND meetings
- End-of-phase 1 and end-of-phase 2 meetings
- Special protocol assistance
- Scientific advice: EMA and National
- Orphan drug pre-submission meetings
- PMDA consultation
- MAA pre-submission meetings
- PIP consultation
- Request for designation
Specific support for Adaptive Clinical Trials
The combination of the Aptiv Solutions regulatory experience in seeking agency advice with our adaptive trial design expertise will greatly facilitate the process for gaining regulatory approval for simple and complex adaptive trials.
Aptiv Solutions can provide clients with the necessary legal representation to cover a range of regulatory activities:
- Legal Representative for Clinical Trials in Europe
- Authorized Representative for Medical Device Trials in Europe
- FDA Agent in US
- DMF Agent in US
Regulatory Submission Management
Aptiv Solutions has expertise and experience in the authorship, preparation and management all types of regulatory documentation associated with drug development, regulatory approval and maintenance.
- Full IND/CTA service including Adaptive Clinical Trials
- Drug Master Files
- Pediatric Investigational Plans
- Orphan Drug Applications
- Marketing Authorizations (NDAs, BLAs, MAAs)
- Established drugs: 505(b)2s, “Hybrids”, ANDAs, Generics
- Risk Management Plans
- CE Marks
Aptiv Solutions has significant experience in gaining regulatory approval for the development and marketing of Orphan Drugs in Europe, US/Canada and Japan. This expertise covers:
- Medical and regulatory review of potential indications
- Orphan Drug Designation
- Scientific Advice/Protocol Assistance
- Orphan Medicinal Product Application pre-submission meetings
Importantly, regulatory agencies advocate the use of Adaptive Clinical Trials for the development of orphan drugs and Aptiv Solutions regulatory team, in conjunction with our adaptive design experts, can assist sponsor companies in the design and implementation of clinical studies in a wide variety of orphan indications
Pediatric Investigational Plans (PIP)
Since the EU Pediatric Regulation came into force in 2007, our regulatory experts have worked with sponsor companies to provide solutions to meet the requirements of this legislation.
The Pediatric Investigation Plan (PIP) is a key aspect of this EU Regulation and poses a challenge for many pharmaceutical companies although it represents an opportunity for additional market exclusivity.
Submission of a PIP and/or a waiver request is obligatory for new medicinal products and also for development of new indications, routes of administration or new pharmaceutical forms for marketed products. Aptiv Solutions is uniquely placed to advise on regulatory and clinical aspects of how and when the PIP should be produced. This includes:
- The generation the high quality documentation to comply with the regulations
- An effective interface with the Pediatric Development Committee (PDCO)
- The design and implementation of non-clinical and clinical studies
The Aptiv Solutions global e-Publishing team will assemble, review, publish and manage sponsor regulatory documentation. The Aptiv Solutions publishing team has significant experience with European and North American regulatory agencies covering all forms of regulatory submission.
- Documentation clean up and formatting
- eCTD publishing
- Non eCTD Electronic Submissions (NEES) and paper submissions
- Comprehensive dossier life cycle management