Consulting Services

 

SVC consults in regulatory affairs, product manufacture, and research pertaining to veterinary pharmaceuticals and biologicals.

U.S. Department of Agriculture

 

 

· Regulatory planning for product development  

· Regulatory conferencing with USDA 

· Outlines of production

· Regulatory submissions

– Product licenses

– Establishment licenses

– Permits

– Product labels

– USDA facility/personnel documents

– Modified-live and biotechnology-derived products (SIF)

– Master seed and cell characterization reports

– Serial release

– Immunodiagnostic test kits

· Canadian veterinary biologics

· Test facility sourcing, negotiation, and contracts

· Standard operating procedures

· Study monitoring

· Quality assurance under Good Laboratory Practice (GLP²) regulations and Good Clinical Practice (GCP³) guidance. 

· Biofluids analysis and method validation

· Data auditing and statistical analysis

· Scientific reporting

· Regulatory compliance and site inspection

 

U.S. Food and Drug Administration

(Center for Veterinary Medicine)

 

· Regulatory planning for product development  

· Regulatory conferencing with FDA CVM

· Product label reviews

· Regulatory submissions

– Citizen/suitability petitions

– Investigational New Animal Drug (INAD) exemptions

– Veterinary drug master files for drug substances and other proprietary information

– New and abbreviated (generic) animal drug applications (NADA and ANADA)

– Drug establishment and drug listings

– Post-approval documentation (e.g., supplemental NADAs, drug experience reports, adverse drug reaction reports, product defect reports, promotional labeling, CMC updates)

· Other regulatory submissions

REGULATORY AFFAIRS

Schafer Veterinary Consultants, LLC

Worldwide consulting services since 1986.

PRODUCT MANUFACTURE

RESEARCH

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¹ Good Manufacturing Practice, U.S. Code of Federal Regulations, Title 21.

² Good Laboratory Practice for Nonclinical Laboratory Studies, U.S. Code of Federal Regulations, Title 21, Part 58.  

³ Good Clinical Practice, Guidance GL9, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), June 2000, FDA Guidance No. 85, May 2001.

Pharmaceuticals

 

· Process and equipment validation

· Equipment cleaning validation

· Process manufacturing and packaging

· Product analysis and method validation

· Stability testing

· Quality control

· Master production records

· Good Manufacturing Practice (GMP¹) compliance, site inspection

· Standard operating procedures 

Biologicals

 

· Serial release and potency test development

· Target animal safety studies (toxicity, drug tolerance)

· Human food safety studies (tissue residue, metabolism)

· Field safety studies (USDA)

· Back-passage safety studies for modified-live products (USDA)

· Efficacy studies (bioavailability, bioequivalence, dose determination and confirmation, field trials)

· Freedom of Information and literature searches

· Study design, protocol development, and data collection forms