With a rich legacy, we have consistently pushed the boundaries of scientific discovery to bring BREAKTHROUGH medicines and therapies.

Survey No.1411, Ishnav -Trambovad Road,AT- Kasor - 388460, Sojitra , Anand, Gujrat, India.

+91 99747 35938

operations@apteekhealthcare.com | pratik.patel@apteekhealthcare.com

Consultancy

Global Regulatory [Regulated & Emerging Markets]

Build Global Regulatory Strategies
Build Clinical Development Strategies
Build Formulation Development Strategies
Technical/Consultancy support during pre-IND/NDA, Scientific advice with regulatory agencies
Due Diligence of dossiers for global markets
Authoring administrative (m1) and technical sections (m2 to m5) of dossier (CTD format) eCTD Publishing services for CTD dossiers
Life-cycle management services (variations / post-approval changes)
Support during the technical query response from the regulatory agencies.
Review of technical (CMC) documents, bioequivalence protocol and clinical study protocols.

Domestic Regulatory, India [Liaison Services]

CDSCO – CT application, Dual Use, Export NOC, Written Confirmation.
(COPP), Free sale Certificate (FSC), Wholesale License, Retail License, Manufacturing License, GMP & GLP Certificate, WHO-GMP Certificate, Loan License.
State FDA – Product permission, Certificate of pharmaceuticals Product (COPP), Free sale Certificate (FSC), Wholesale License, Retail License, Manufacturing License, GMP & GLP Certificate, WHO-GMP Certificate, Loan License.
Central Bureau of Narcotics (CBN) – Company Registration, Product Registration, Export & Import NOC, Quota Registration.
Due Diligence of dossiers for global markets
Narcotics Central Bureau (NCB) – Acetic Anhydrous Registration, Product Addition & Quota enhance.

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