Regulators are applying higher levels of scrutiny and manufacturers are looking ever more critically at a new drug development process largely conceived in an era of blockbusters.
While innovation is being applied to solve the challenges of science and technology, successfully achieving regulatory approval and reimbursement demands even more - a REINVENTION of the development process, with new vitality applied to the integration of clinical and regulatory strategies that drive commercial success.
As a result, companies are examining every aspect of their development processes: How can they optimize their portfolio for commercial success? How can they make more informed go/no-go decisions? How can they effectively leverage rapid approval programs? Developers need to know how to navigate regulatory regimes across the globe, how to make smarter advancement decisions, and how to integrate powerful new outsourcing solutions into their operational strategies.
Consulting services overcomes the obstacles to get products to market faster and smarter.
Regulatory consulting expertise help you obtain global product approval and maintain filings throughout the entire product lifecycle.
Every day your therapy sits in the development pipeline costs you money and costs patients the opportunity for treatment. To get it right the first time at every step of the development process for your pharmaceutical, biotechnology and medical device products is crucial.
Regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on your research investments. Efficient scientific and regulatory consulting services throughout the full product lifecycle help ensure the continued success of product post-approval.
Drug development areas of expertise in human and animal health, Ophan drugs, Small molecules and biological products, New chemical entities and generic product development, Active pharmaceutical ingredients (APIs), Finished products, Medical devices etc.
Preparation of regulatory dossiers, including components of: Pre-Investigational New Animal Drug (Pre-INAD) meeting requests and meeting information packages, investigational New Animal Drug (INAD) applications, generic Investigational New Animal Drug (JINAD) applications, New Animal Drug Applications (NADAs), Abbreviated New Animal Drug Applications (ANADAs)
Preparation and review of labeling and promotional documentation, obtaining and maintaining the necessary state licenses for distribution. Lifecycle management services post-approval.
Animal health consulting services can be provided for unapproved animal health products, as well. Examples of these products include grooming aids, medicated grooming aids and nutritional supplements. Regulatory consulting services for animal health products regulated by authorities other than the CVM, including biologics (US Department of Agriculture [USDA]) and radiation-emitting devices (FDA Center for Devices and Radiological Health [CDRH]), services customized to fit any development program for drug products, including Minor Use and Minor Species (MUMS) products and conditional approvals for drug products.
FDA guidance documents, requirements of the International Conference on Harmonisation and other global regulatory agencies are considered for currently marketed products to ensure attention to detail in the preparation and submission of regulatory documents. This strategy has successfully helped clients reduce development time and accelerate the movement of new products to proof-of-concept and global commercialization for pharmaceuticals, biologics and medical devices.
Experience in all major therapeutic areas and have had successful interactions with all regulatory divisions within the FDA and several other global regulatory agencies. Support product development throughout the entire development continuum, from concept and strategic development, to proof-of-concept and market approval, to post-approval maintenance. Regulatory affairs solutions for full product lifecycle management. Regulatory expertise also includes solutions to help clients navigate the complex requirements for orphan drug development and the FDA expedited programs.
Sponsors face a number of challenges during the product development and marketing application processes. Additional challenges are added to the mix during the development and approval processes for drugs, biologics and medical devices that diagnose, treat, cure, mitigate or prevent orphan diseases, ultra-orphan diseases or rare pediatric diseases. Specialty Solutions provide the expertise needed to navigate through the complex development and regulatory processes involved in advancing orphan drug.
A disease that affects fewer than 200,000 people in the United States or that affects more than 200,000 people but is not expected to recover the costs of developing and marketing a drug. Orpdan drugs and biologics are developed to diagnose, treat or prevent a rare disease.
An orphan disease in which more than 50% of the affected population in the United States is 0 to 18 years of age.
More than 25 million patients suffer from an orphan disease. The Orphan Drug Act was passed in 1983 to stimulate development of therapies to help these patients.
A medical device that is intended to benefit patients by diagnosing or treating a disease or condition that affects fewer than 4,000 individuals in the United States per year.
Consulting services to help companies through the entire orphan drug and device development process, including product analysis, orphan drug designation request, humanitarian use device designation request, regulatory application preparation and post-approval requirements.
The guidance is provided to yield full benefits of programs like Fast track designation, breakthrough therapy designation, accelerated approval pathway, priority review designation or a combination of the four expedited programs. Additional support for regulatory documentation preparation and negotiations with the FDA.
Our nonclinical team is composed of industry experts and former FDA consultants averaging 17 years of experience in the pharmaceutical industry. Our experience allows us to provide streamlined development plans and regulatory strategies that add value to your nonclinical development program. Our nonclinical consultants have led development teams in all major therapeutic areas, including programs for small molecules, biologics, biosimilars, vaccines and devices.
Clinical development, Clinical research including clinical development planning, clinical trial design and protocol development, medical writing services, due diligence assessment and gap analysis, identification and management of key clinical resources and thought leaders, interfacing with industry experts and regulatory authorities clinical operations such as clinical trial management and monitoring, clinical research organization and vendor qualification and management, trial master file creation and maintenance. Clinical quality compliance audits, including Good Clinical Practices (GCP) and pharmacovigilance (PV) audits, standard operating procedure (SOP) development, training programs, project management. Regulatory dossier authoring services include investigational applications and maintenance, Investigational New Drug (IND) applications, Clinical study reports (CSRs), Patient narratives, Study protocols and amendments, Pediatric study plans (PSPs), Risk management plans (RMPs), Manuscripts, Investigator’s brochures, Safety reports (Development Safety Update Report [DSUR] and IND annual reports), Meeting information packages for regulatory agency meetings.
Marketing applications (original applications, amendments and post-approval submissions) such as New Drug Applications (NDAs), Biologics Licensing Applications (BLAs), Marketing Authorization Applications (MAAs), Common Technical Documents (CTDs), Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE) sections, Safety reports (120-day safety updates and Periodic Safety Update Reports [PSURs]), Responses to questions (RTQs) from regulatory agencies.
Regulatory affairs consulting services for small molecules, biologics and medical devices as well as products in all major dosage forms.
Regulatory documentation preparation, review and maintenance
CMC documentation (Common Technical Document [CTD] module 3) for drug substances and drug products, Product development reports, Protocols, such as method validation, process validation and comparability, Drug Master Files (DMFs) for the United States, Canada, Europe and other regions, including serving as US Agent
Technical guidance include: Analytical method development and validation (including vendor selection, qualification and oversight), Formulation and process development, manufacturing and process validation (including vendor selection, qualification and oversight), Management of clinical trial material production.
Regulatory guidance like Development of global regulatory strategies, Design and management of active pharmaceutical ingredient (API) and drug product (finished formulation) development plans, Quality assurance guidance relating to pre- and post-approval CMC changes, Guidance on FDA and global regulatory requirements, regulations and guidances, Development of quality assurance programs, including quality systems and standard operations procedures (SOPs), Post-approval support (such as annual reports and prior approval supplements), Due diligence reviews of development programs, marketing applications and manufacturing sites, Management of registered information for global products.
Regulatory agency audits through the execution of regulatory compliance and GXP auditing services.
Pharmaceutical auditing expertise include Pre-approval Inspection (PAI) readiness, Good Manufacturing Practices (GMP) audits, Good Laboratory Practices (GLP) audits, Good Clinical Practices (GCP) audits, Quality System Regulations (QSR), Supplier Qualification audits.
Complete eCTD submission solutions with no overhead investment (e.g., hardware and software) by your company, eCTD publishing and submission capabilities to meet PDUFA V eCTD requirements, Complete solutions for publishing of CSRs in eCTD-compliant and/or ICH E3 format to ensure reports are submission ready for investigational and marketing applications, Efficient maintenance and lifecycle management of regulatory dossiers, Complete solutions for outsourced publishing (full and partial dossiers), Publishing deliverables prepared in your systems using your tools and processes, Complete solutions for paper trial master file (TMF) document indexing, scanning and archiving, Complete solutions for preparation and submission of electronic drug listings, establishment registrations, labeler code registrations, lot distribution reports and GDFSI files, Structured product labelling, Access to eCTD experts for submission planning, placement of content within the eCTD structure and the development of detailed submission plans/maps, Expert consulting services regarding FDA requirements, Project-based, overflow or long-term engagements.
Pharmacovigilance Consulting Services include: Product Safety Strategy, Review data from multiple sources to determine safety profile, Develop core documents - Investigator Brochure, Core Data Sheet, Risk Management Plan, determine and implement signaling strategy, develop and implement proactive postmarketing surveillance strategy; Postmarketing Safety Surveillance and Analysis, perform all aspects of signal management, design and execution of postmarketing clinical registries, design and execution of prospective surveillance similar to FDA PROMPT, respond to Health Authority inquiries, handle urgent safety issues, Perform hazard analysis for potential recalls