Our Services
REGULATORY STRATEGY AND LEADERSHIP
Generation and execution of product and indication specific regulatory strategy, in line with corporate objectives
REGULATORY AND MEDICAL WRITING
Proficient regulatory, technical (non-clinical and clinical) and medical writing capability
SUBMISSION PLANNING AND SUPPORT
Project management of regulatory submissions, managing cross-functional teams from planning to submission
TECHNICAL DEVELOPMENT STRATEGY
Non-clinical and clinical development advice, with experience in a wide a range of product types and therapeutic indications.
ORPHAN AND PEDIATRIC DISEASE DEVELOPMENT
Authoring and/or review of required regulatory documentation and technical support on development expectations.
OUR SERVICES
Regulatory Strategy & Leadership
Ramp Regulatory can provide regulatory strategy input and leadership covering EU, US and UK regions of interest. We can:
Develop and design regulatory strategies, tailored to a medicinal product type, region(s) of interest, and target therapeutic indication(s), in line with corporate goals.
Operationalize regulatory strategy, educating stakeholders on regulatory expectations (as required).
Review existing regulatory strategies and identify opportunities and challenges in the regulatory landscape.
OUR SERVICES
Regulatory and Medical Writing
At Ramp Regulatory, we can:
Prepare regulatory documentation including authoring, reviewing and/or maintenance of initial applications (i.e. CTD, M1, M2.4 - 2.7), amendments, responses to information requests, meeting background materials/scientific advice to support Regulatory Authority interactions, INDs, CTAs, annual reports, IND safety reports/DSURs, and correspondence.
Prepare and/or review a wide-range of pre-market regulatory documents for expedited pathway requests (e.g. FTD, BTD, RMAT, ILAP, PRIME).
Undertake medical writing activities such as IB and clinical trial protocol authoring or review.
OUR SERVICES
Submission Planning and Support
Ramp Regulatory can provide you with a roadmap and timelines to meet your submission goals. We can:
Plan and project manage a submission, leading cross-functional teams to develop high quality, regulatory compliant submissions in an efficient manner.
Execute regulatory submissions on behalf of our clients.
Advise on submission strategy and execution for multi-jurisdiction applications to maximise efficiency and increase likelihood of success.
OUR SERVICES
Technical Development Strategy
At Ramp Regulatory, we provide technical input on regulatory expectations for development. We can:
Review non-clinical and/or clinical data, and determine extent of support for regulatory submissions.
Provide input on study design/ methodology, with respect to likelihood of regulatory acceptance.
Support the conduct of due diligence and gap analysis activities, specific to development phase and region of interest from a non-clinical and clinical perspective.
OUR SERVICES
Orphan Drug Development
Support for clients developing orphan drugs may include:
Conducting feasibility assessments for achieving orphan designation in the EU, US or UK.
Authoring/review of orphan designation applications including prevalence estimates.
Providing input on data/market exclusivity entitlements in the US/EU/UK associated with orphan designation (and potential regulatory barriers to market access).
Providing non-clinical and clinical technical input on regulatory expectations for orphan medicinal product development.
Pediatric development support may include:
Providing input on paediatric development expectations, in line with regulatory requirements in the US/EU/UK.
Authoring/review of: Paediatric Investigation Plans (PIPs, UK-PIPs) and waivers; PIP requests for modification; and, Pediatric Study Plans (iPSPs).
Procedural and submission support
Preparation/review of Rare Pediatric Disease Designation applications.
Pediatric Drug Development
Do you need additional support in your team?
Get in touch and we would be happy to organize a call to discuss ways in which we may be able to work together