Scientific and Regulatory Consulting
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Cardinal Health Specialty Solutions provides a wide range of scientific and regulatory consulting services from early phase drug development through product commercialization for the biotech, pharmaceutical and medical device industries in the U.S. and international markets. We manage the time consuming and complex regulatory process by designing and implementing efficient global scientific and regulatory strategies. Through our scientific and regulatory consulting business, formerly known as Beckloff Associates, we have more than 35 years of strategic drug development and regulatory consulting experience.
Why select Specialty Solutions for your scientific and regulatory needs?
- A track record of success spanning four decades and over 200 clients
- Experience with all classes of pharmaceutical and medical device products
- A strategic global approach to regulatory planning and product development
- Established relationships with regulatory agencies worldwide
- Continuity of service from the laboratory to the market and beyond
- The leveraged resources of a Fortune 20 company
Worldwide scientific regulatory strategies
With our unmatched expertise in regulatory affairs and documentation, we provide customized product development solutions that can meet even the most complex regulatory environment.
Long-term interactions with all regulatory divisions in the FDA ─ including the Center for Drug Evaluation and Research (CDER), the Center for Biological Evaluation and Research (CBER) and the Center for Device and Radiological Health (CDRH).
- Preparation and/or maintenance of regulatory documentation
- Electronic submissions expertise
- Common Technical Document (CTD) expertise
- REMS design, implementation and analytics
Strategic planning and general drug development
We provide regulatory and product-planning services that help prevent excessive development costs, delayed regulatory submissions and other setbacks that detract from a product’s profitability.
- Regulatory guidance and management in all phases of product development and document submissions
- Product potential analysis and product development plans
- Development and coordination of worldwide submission objectives
- Guidance on development strategies, responses to warning letters, inspections and clinical events
- Information research and expert-opinion reports
- Meetings with regulatory authorities regarding drug development programs
Regulatory publishing services
Our expertise encompasses paper and electronic regulatory submissions, study reports and publications.
Our services include:
- Utilization of a validated publishing system
- Creation of submission and/or publication outlines for organization of information
- Conversion of source documents into electronically compliant PDF files
- Compilation of electronic regulatory submissions according to the eCTD guidelines
- Consulting and training services
State Licensing services
State Licensing for drug products and devices is required by most states and needs to be in place prior to distribution of products to that state. If your company is a manufacturer (contract, virtual, foreign, or sampling), wholesaler or distributor, contract sales organization, broker, third party logistic provider (3PL), importer or exporter, researcher or laboratory, nonresident or mail order pharmacy you will need to have state licensing in place prior to the products sale and distribution. Beckloff Associates, through its experienced staff and management systems, can support all your state licensing needs.
- Services to obtain, complete and submit necessary forms and follow-up to obtain state licenses for required states (each state has its own forms and requirements) according to client needs.
- We maintain client state license database and update state registrations on ongoing basis (each state has different requirements for renewal)
- Extensive experience with Federal and State registration and licensing requirements and application process for drug products and devices
- In-house management system for periodic registration updates for each state
Non-clinical and clinical development
Integrating clinical and non-clinical services to facilitate rapid development of new products to worldwide markets.
- Program management
- Development plans
- Clinical study design and protocol development
- Medical writing expertise for clinical study report preparation (CSRs, PSURs and other documentation)
- Broad therapeutic knowledge in Oncology, Hematology, Analgesia, Anti-Infective, Cardiology, CNS, Dermatology, Endocrinology, Gastroenterology.Inflammation/Pain, Infectious Disease, Nephrology, Pulmonary, Rheumatology, Urology
- Selection, qualification, management and monitoring of clinical study sites
- Current Good Laboratory Practices (cGLP)
- Compliance and quality services (GLP, GMP, GCP, QSR)
Developing strategic plans, analysis of scientific data, and designing optimization strategies for delivery of scientific or clinical messages.
- Publication plans
- Manuscript, abstract and posters
- Editorials, supplements, book chapters
- Slide Decks
- Investigator meetings
- Advisory boards
- Round table discussions
- Web-ex programs
- KOL profiling and development
- Poster Sessions
Chemistry, manufacturing and controls (CMC)
Our scientific team specializes in the management of analytical methodologies, formulation studies and manufacturing data that are used to support your products and prepare your regulatory submissions.
- Preparation of CMC documentation for drug substances and finished formulations
- Analytical methods development and validation
- Preformulation study design
- Regulatory specification development
- Stability study design
- Physicochemical characterization and structure elucidation
- Process evaluation and vendor qualification programs
- Preparation of analytical methods transfer protocols
- Formulation design and strategies
We conduct compliance audits of manufacturing, testing, nonclinical and clinical facilities to assist companies and their vendors in attaining compliance with CGMP, GLP and GCP regulations.
Our training workshops provide participants and their companies with the opportunity to benefit from our wide-ranging experience in the pharmaceutical industry. Customized workshops are available upon request.