Creative Consultants



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Registration Dossiers
SPC
Preclinical Overview (CTD)
Clinical Overview (CTD)
Package Inserts
Patient Leaflets
 Medical Writing

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Summary of Product Characteristics (SPC) 

The SPC is the basis of information for health professionals on how to use the medicinal product safely and effectively. The SPC provides  the framework for preparation of expert reports. Information in SPC is provided under the following heads:

1.  Trade Name of the Medicinal Product
2. Qualitative and Quantitative composition
3. Pharmaceutical Form  
4. Clinical Particulars
a. Therapeutic indications
b. Posology and method of administration
c. Contra-indications
d. Interaction with other medicaments and other forms of interaction
e. Special warnings and precautions for use
f. Pregnancy and lactation
g. Effects on ability to drive and use machines
h. Undesirable effects
i. Overdose
5. Pharmacological Properties
a. Pharmacodynamic properties
b. Pharmacokinetic properties
c. Preclinical safety data
6. Pharmaceutical Particulars
a. List of excipients
b. Incompatibilities
c. Shelf-life
d. Special precautions for storage
e. Nature and contents of the container  
f. Instructions for use/handling  
7. Marketing Authorisation Holder
8. Marketing authorisation number(s)
9. Date of 1st authorization/ renewal of the authorization
10. Date of (partial) revision of the text

We can prepare SPC on any product with minimum inputs from our clients. Click here to view specimen of SPC prepared by us.