medical writing acpl

ACCREDITED CONSULTANTS PVT LTD. (ACPL)

WELCOMES YOU

ACCREDITED CONSULTANTS PVT LTD

MEDICAL WRITING SERVICES

CLINICAL & REGULATORY

WRITING SERVICES


WHAT WE HAVE?

• Expert team providing excellent quality services delivery within time to our clients at highly competitive prices.


WHAT WE DELIVER?

• We provide Medical Writing Services entailing the generation of well‐structured individual reports supporting extensive medical writing programs.


DRUG SAFETY

• Aggregate & Periodic Report Writing & Submission

• PSURs/PBRERs/PADERs/DSURs writing

• Pharmaceutical Risk Management Plans (RMP)


CLINICAL WRITING

• SAE Narratives for Clinical Study Reports

• Clinical Study Reports

• Clinical Summaries/Product Feasibility Reports for Medical Devices

• Annual safety report writing

• Patient Diary Cards (PDC), Informed Consent Form (ICF), Case Report Forms (CRFs) etc.


REGULATORY AFFAIRS

• Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS)

• Summary of Product Characteristics (SmPC), Pack Insert and Local Labels

• Proficiency in creating detailed NDA, ANDA and IND applications (Module 1 ,2,3,4)


OUR AIM

• Our expert team undergo regular training to ensure the adherence of regulatory standards and have consistency across writing processes as per our client needs


GOALS AND PLANS • Offshore delivery success including experience in

Clinical development services, Pharmacovigilance and Regulatory

• Life Sciences industry achieve better services through our regulatory compliance, higher productivity, higher quality and strategic outcomes


WHY ACPL? • Our services deliver measurable outcomes for our

clients

• We have a expertise team who had worked earlier with top most pharmaceutical companies worldwide.

• We provide clinical, regulatory and post marketing services under a single umbrella with cost-effective measures.


ACCREDITED CONSULTANTS PVT LTD. D-29, First Floor, Acharya Niketan

Mayur Vihar-I Delhi-110091, India

Ph: +919310040434, +9122758204 Fax: +91 22758994

email: [email protected] Client Care: [email protected]


mailto:[email protected]



medical writing acpl

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