Our team of dedicated regulatory affairs specialists will provide solutions and meet any needs of the regulatory science for your business. We will provide comprehensive Regulatory Intelligence and work with you on choosing the right regulatory pathway for your product. We have international expertise and cover global markets.
Industries Covered:
Pharmaceutical:
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•Drugs
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•Biological Products
Medical Devices
Laboratory/Diagnostic Products
General Services:
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• Regulatory Intelligence
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• Regulatory Strategy Development
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• Technical and Scientific Writing
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• Regulatory Submissions
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• Advertising and Promotion
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•Audit
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•Training
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•FDA communications
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•Response to Warning letters( FDA Form 384)
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•cGMP certification
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•CMP certification
Market Specific Services:
USA/FDA:
Regulatory pathways/applications:
IND, NDA,ANDA,BLA, IDE, PMA, 510(k)
Codes/Standards/Guidelines:
21CFR, cGMP, QSR/ISO 13485, ICH, GCP
Post marketing surveillance
European Union
EU regulations: MDD, AIMD, IVD directives.
CE Marking, Conformity Assessment,
Common Technical Documentation, Notified Body Certification
Common Technical Document preparation and submission
OTHER COVERED MARKETS:
CANADA
Regulatory Authority: Canada Health
AUSTRALIA
Regulatory Authority: TGA
NEW ZEALAND
Regulatory Authority: MEDSAFE
JAPAN
Regulatory Authority: MHLW(PMDA&PAL)
CHINA
Regulatory Authority: SFDA
EMERGING MARKETS:
RUSSIA
Regulatory Authority: Roszdravnadzor
INDIA
Regulatory Authority: CDSCO
SOUTH KOREA
Regulatory Authority: KFDA
TAIWAN
Regulatory Authority: TFDA
MALAYSIA
Regulatory Authority: MDCD
SINGAPORE
Regulatory Authority: HSA;CDA
BRAZIL
Regulatory Authority: ANVISA
MEXICO
Regulatory Authority: COFEPRIS
COLUMBIA
Regulatory Authority: INVIMA
ARGENTINA
Regulatory Authority: ANMAT
EASTERN EUROPE:
Ukraine,Georgia,Azerbaijan, Armenia
contact us: Email: jkmd@jkmdgms.com Tel: +1(857) 574-0660
