Callum Consultancy provides expertise to small and growing pharmaceutical companies and research facilities
throughout the world.
Dosage Form Design
Converting an active pharmaceutical ingredient to a Medicinal Product requires extensive appreciation and understanding of the biological and physico chemical properties of the drug, the clinical condition and the end-user (patient) along with many other considerations. Each drug has unique requirements that need to be factored in to the product design. There is no “one size fits all” formula, nor single technology that can be applied to all compounds. Furthermore, the composition may need to be changed during development as knowledge accumulates on the effective dose, bioavailability, long term stability and many other considerations.
In the light of such complexity much resource could be expended on dosage form development, while evaluating a potentially useful material. It is vital therefore that a pragmatic as well as knowledgeable approach is adopted in an evaluation program for a novel molecular entity or life cycle management program. Callum Consultancy guarantees an efficient, cost-sensitive approach and has access to a wide network of associates with much experience in technologies, regulatory considerations and preclinical/clinical development programs.
The current emphasis on “knowledge-based” rather than data-based product filings under the aegis of “Quality by Design” makes it imperative that new product filings or updates for existing products are written to “educate” Agency Reviewers and articulate complex relationships in “easy-to-understand” explications that reassure the Reviewer that the Company understands the product and process.
This desired state may be difficult to attain. Members of data-generating groups, while excellent scientists may not have good written communication skills, nor enjoy constructing such treatises. Regulatory Affairs professionals may lack the in-depth technical understanding required to weave different sets of data into a coherent “story” of what it means for product quality or performance. The compilation of high-quality documentation is a particular skill offered by Callum Consultancy that has been developed over many years’ dialogue with Regulatory Agencies, including the construction of Expert Reports and Quality Overall Summaries.
It is important that regulatory filings for new products or those concerning process and site changes, shelf life extensions as well as responses to questions from Agencies are positioned and presented in an authoritative and persuasive way, so that the company’s position is sustained and prevails. Patrick Crowley has been heavily involved in regulatory filings, worldwide throughout his career, whether in the construction of documentation, meetings with regulatory agencies and contributions to industry positions in the development of Guidelines.
Too often, training comprises “talking through” an SOP. This is not denigrating the use of procedures to ensure consistency but training can be most effective if interesting, interactive and based on good science. Callum Consultancy offers specific training modules in various facets of pharmaceutical development such as dosage form design, absorption enhancement, drug and product stability, packaging, Quality by Design” and writing for regulatory filings.
Much creative science is carried out in small (startup) organizations. However, the critical mass, and expertise for later-stage clinical and safety evaluation of promising molecules remains with larger Pharmaceutical companies, and contract organizations. Many startup organizations have an understandable minimalist approach to activities such as preformulation studies, dosage form development, processes for manufacture etc. It is important therefore that the due diligence, to assess whether the modest studies carried out are adequate to support claims on the molecule’s performance, or could delay progression to the larger studies to determine safety and efficacy.
The combination of skills at Callum Consultancy ensures that due diligence activities, be they site visits and discussions or critique of written documentation/data is insightful and valuable in the decision-making process.
Patrick Crowley has defended patent claims in person in litigation in the High Court (UK), Germany, Portugal, Holland (EU Patent Court) and the United States. He has worked with Patent Attorneys and Legal Counsel, preparing written depositions in many other countries (providing notarized evidence and statements).
He has also lectured at Training Programs at the US Patent Office (topic: dosage form development).
Pharmaceutical products require consistent support throughout their life cycles, particularly if the drug is of biological or semi synthetic provenance. Support may comprise trouble shooting, efficiency-enhancements, site transfers, scale changes etc.
It may be possible to extend life cycle by designing an improved dosage form. Callum Consultancy has much experience and interest in these areas, as will be evident from publications authored by Patrick Crowley.
Callum Consultancy was founded by Patrick Crowley after retiring from GlaxoSmithKline as a Vice President
in Pharmaceutical Development.
Patrick Crowley brings over 40 years of experience in Dosage Form Development in R&D-based organizations. He has helped design and obtain regulatory approval for 15 commercial products; including NCE's, Line Extensions, Semi Synthetics, Fermentation products and a Biopharm product.
Callum Consultancy provides services to:
- Small to medium-sized Pharmaceutical Companies that require expertise in dosage form development, testing and integration of activities with overall development programs and regulatory filings.
- Startup organizations or University Research Groups that need expertise in progressing novel assets to clinical evaluation and commercialization.
- Large Pharmaceutical organizations requiring expertise in a specific area of Drug Development or Regulatory filings.
You Need Us If...
You are a Small to Mid-Sized Phamaceutical Company
that needs outside assistance from time to time.
You are a young and growing or Start-up Pharmaceutical
company looking to add to your expertise and streamline
You are a University Research
Department with a promising drug lead.
The Callum Advantage:
- Over 40 years Experience
- Skilled Regulatory Writer
- Due Diligence Expertise
- Expert Witness in Patent Litigation
- Experienced Trainer and Lecturer
Our specialties include Consulting on Dosage Form Design,
Pharmaceutical Development, Life Cycle Management, Drug Stability,
Regulatory Writeups, and many other areas. See our Consulting
and Services pages for more details and additional services.
In My Opinion...