CATO SMS has the advantage of integrated regulatory, clinical, and scientific expertise. The Consulting and Development Services business unit provides full consulting services to the pharmaceutical, biotechnology, and medical device industries. We specialize in complex development programs requiring innovative regulatory strategies.

Our experienced global team offers services in pharmaceutical and preclinical development through IND (or equivalent), clinical development, and marketing approval including Phase IV post-marketing research. Our track record includes successes across many different health products, including drugs, biologics, vaccines, cell therapies (including stem cells), nutraceuticals, medical foods, devices, and diagnostics.

The Consulting and Development Services business unit offers first-line consulting expertise to initiate evaluation and strategy dialogue, offering clients access to design and execution of full product development programs including, but not limited to:

  • Product Development Strategy and Planning
  • Target Product Profile (TPP)
  • Clinical Development Plan
  • Regulatory Development Strategy & Submissions
  • Clinical Pharmacology
  • Nonclinical/Safety Strategies
  • Gap Analysis, Critical Risk Identification, and Contingency Planning

Our experts are seasoned professionals who have significant work experience within the medical device, pharmaceutical, and biotechnology industries, collectively participating in the development of more than 50 approved products.

Continuous innovation in healthcare technologies means that regulations are dynamic. Regulatory affairs ensure that companies, their products, and their process for developing new products meet international and local regulations and requirements.

Knowledge of the regulations is not enough. Familiarity with the various regulatory groups (FDA, Health Canada, EMA, and more) and their preferences is essential to achieve the most efficient and successful outcomes. This familiarity comes from frequent interactions with different regulatory sections, including the presentation of challenging and innovative products.

Our regulatory group completes approximately 750 submissions of various types annually.

CATO SMS has more than 30 years of experience in regulatory affairs for small and emerging biopharma, including ongoing interactions with regulators for a wide variety of products and technologies. We provide expert regulatory solutions, including the following:

  • Regulatory strategy throughout the life cycle of your product
  • Regulatory contact capabilities
  • Regulatory submissions
  • Medical writing

Choosing the right regulatory strategy can mean the difference between a streamlined approval process or a drawn-out, expensive process. We have the expertise and track record to design effective regulatory strategies to ensure an efficient approval process.

Throughout the regulatory process, our experienced Ph.D., Pharm.D., and M.D. level writers will guarantee your regulatory strategy is efficiently translated into the right documents for the regulatory agency review, including:

  • IND filings (North America)
  • CTA submissions (Europe & Canada)
  • NDAs and BLAs
  • ITAs (Europe & Canada)
  • IDEs, 510(k)s, and PMAs
  • Orphan drug designation applications
  • Fast track applications
  • Request for designation
  • Special protocol assessments
  • Recombinant DNA Advisory Committee (RAC) meetings

We have extensive experience in eCTD/ICH formats, including assisting sponsors with the transition from paper to electronic regulatory submissions. Our electronic submission software uses LORENZ docuBridge, the same software used by the FDA for viewing electronic submissions. We have never received a refuse-to-file from the FDA.

CATO SMS’ skilled multidisciplinary team will ensure the content, accuracy, and presentation of any document meets the highest quality standards. Our medical writers achieve this in close collaboration with experts across all disciplines — medical, clinical, regulatory, and scientific teams.

Tasks span the entire process from drafting, reviewing, and updating to full writing of regulatory documents, supporting our sponsors with high-quality documents that meet all GCP and industry standards, including:

Full medical writing services

  • Investigational Medicinal Product Dossier (IMPD)
  • Investigational New Drug (IND) file
  • Investigator Brochure (IB)
  • Protocol (synopsis) development
  • Study, country, and site specific master informed consent forms (ICFs)
  • ICH E3 compliant clinical study report (CSR)

CATO SMS’ seasoned CMC scientists ensure the quality, consistency, and technical validity of the CMC program, conform to the various global regulatory requirements and quality standards, and provide the appropriate level of detail for the specific submission.

Whether your needs are comprehensive or tightly focused on a specific project, our experienced CMC team will help keep your development program on track.

Our services include:

  • Chemical Development
  • Biopharmaceutical Development
  • Drug Product Development
  • Regulatory
  • Quality
  • Supply Chain and Manufacturing Strategy

CATO SMS’ combination of scientific, technical, and compliance expertise allows us to design tailored nonclinical development programs that meet regulatory agency requirements in the most cost-effective and time-efficient manner without compromising the quality of the overall safety assessment.

Our scope of services includes:

  • Nonclinical development plan, gap analysis and recommendations plan, including estimations of the amount of test article required, study/overall nonclinical program costs, and timeline.
  • Nonclinical study support: Our toxicologists have extensive experience in planning, conducting, and monitoring toxicology studies using a broad variety of routes of administration, and in an array of animal models, including: ADME, safety pharmacology, single- and repeated-dose toxicology, genotoxicity, carcinogenicity, developmental and reproductive toxicology, immunotoxicity, and neurotoxicity studies.
  • Nonclinical regulatory support: Our team is highly experienced with regulatory agencies’ requirements and interactions for nonclinical safety development
    • Pre-IND meeting packages (and in the case of cellular and gene therapy products, pre-pre-IND meeting packages)
    • IND and IDE submissions
    • Clinical Trial Applications (CTAs)
    • End-of-phase meeting packages
    • NDA, BLA, and PMA submissions (eCTD format)

CATO SMS’ regulatory, quality and clinical operations expertise along with a forward thinking mindset allows us to support you in building quality processes within your clinical research programs. We also offer support in investigating and resolving compliance issues in all phases of research and development.  

Our scope of GxP services includes:

  • Audits
    • Routine: conducted while the trial is ongoing
    • Targeted audits (‘for-cause’): conducted to investigate specific areas of concern
  • Regulatory Agency Inspection readiness
  • ‘Back room’ presence during regulatory agency inspections
  • Mock FDA inspections
  • FDA Form 483 and warning letter response assistance
  • Vendor qualification
  • CRA audits
  • Document Audits – includes audits of database in comparison to reports/submissions to regulatory authorities
    • Protocols
    • Informed Consent Forms
    • Investigator Brochures
    • Clinical Study Reports
    • NDA/IND Submissions
  • SOP support
    • Authoring
    • Review
    • Gap analysis
    • Departmental, geographical integration
Toxicology
PK/PD development
Pharmaceutical development
Clinical strategy
Cell & gene therapy