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Our services include
Regulatory Affairs
- Prepare, review and assemble marketing submissions to global
regulatory authorities for the following product categories
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Drugs, including orphan drug and fast track applications
o
Generic drugs
o
Devices, including diagnostics
o
Biologics
o
Veterinary products
- Liaise with health agencies to resolve issues and expedite
marketing approvals
- Provide expert advice on regulatory strategy
- Prepare and implement regulatory Standard Operating Procedures
- Review labeling
and advertising
- Prepare, review and assemble investigational applications,
including verifying and evaluating documentation
- Work at client sites to handle their day-to-day regulatory
operations. Tasks include but are not limited to:
o
Prepare information and protocol amendments, safety reports
and all necessary
correspondence to FDA
o
Audit investigator documentation to ensure all required
documentation is in place per
21CRF 50 and 56 requirements
o
Approve and process shipping orders for investigational use
o
Prepare export documentation for non tier-one countries and
ensure all appropriate
export documentation is in place for tier-one
countries
o
Managed labeling changes for USPI, SmPC and Core Data sheet
o
Review study protocols, study reports, and completed CRFs, for
accuracy /
completeness for submission
- Prepare background documents to health authorities
- Prepare the necessary forms for registration of Drug
Establishment and Drug Product Listings
- Manage / input study information in FDA database for
investigational protocols for serious and life threatening diseases
Periodic and Annual Report Preparation
Prepare periodic and annual reports for submission to
regulatory authorities
United States Agent
Represent international companies as the designated US agent
Chemistry, Manufacturing & Controls Regulatory Affairs (CMC)Prepare, assemble and review CMC sections of human and
veterinary investigational and marketing applications filed to global
regulatory authorities for:
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Parenterals, including pre-filled syringes
o
Solid dosage forms
o
Liquids, suspensions and creams
o
Modified release dosage forms
Prepare, assemble and review sterilization validation
documentation for sterile products
Prepare, assemble and review Drug Master Files
Prepare stability protocols and stability tables for active
pharmaceutical ingredients and drug productsRespond to health authority queries on behalf of client
companies
Contract and monitor analytical methods development studies on
behalf of client companies
Quality Control and Assurance
Carry out comprehensive audits of manufacturing facilities for
compliance with current GMPs/FDA regulations and guidelinesPrepare and implement Standard Operating Procedures for
manufacturing, packaging, labeling and distribution activitiesPrepare quality control laboratory specifications
for:
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Raw materials
o
Intermediate products
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Finished products
Prepare packaging and labeling specifications
Serve as the quality control unit responsible for the lot
release of drug products
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