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Navigating the Complexities of Global Regulatory Compliance In the highly regulated pharmaceutical and healthcare industry, ensuring compliance with evolving global regulatory requirements is crucial for market approval and continued operations. Regulatory affairs play a vital role in securing approvals, maintaining compliance, and mitigating risks associated with drug products, drug substances, and medical devices across different regions.

Alchemy’s Expertise in Regulatory Affairs

Alchemy Translation and Pharma Services Pvt. Ltd. offers end-to-end regulatory support, ensuring that your drug products, drug substances and medical devices comply with international standards. Our services cover regulatory strategy development, dossier preparation, submission management and region-specific regulatory support. Our team of experts ensures seamless interaction with regulatory authorities, facilitating faster approvals and compliance adherence.

Regulatory Affairs Services

Drug Product
Drug Substance
Medical Devices
Region Specific Support
About alchemy

Why Choose Alchemy for Regulatory Affairs?

  • Comprehensive Expertise: Our in-depth knowledge of regulatory guidelines, including FDA, EMA, MHRA, and CDSCO, ensures compliance across multiple jurisdictions.
  • End-to-End Support: From development to post-market compliance, we offer complete lifecycle regulatory management.
  • Customized Solutions: Tailored regulatory strategies based on product type, region, and regulatory body requirements.

Discuss Your Regulatory Needs with Our Experts.

Talk to Our Experts

Request a Quote for Regulatory Support?

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Testimonials

VOICES OF TRUST

Alchemy’s expertise in eCTD submissions made our regulatory approval seamless. Their team’s attention to detail ensured zero deficiencies in our application.”

Global Pharma Company

Regulatory Director
“Their UK/EU representation helped us successfully launch in Europe. The team’s regulatory knowledge is outstanding.”

Biotech Firm

CEO
“From CE marking to post-approval lifecycle management, Alchemy has been an indispensable partner in our regulatory journey.”

Medical Devices Manufacturer

VP
“Navigating complex regulatory frameworks was simplified with Alchemy’s strategic guidance. Their support has been invaluable.”

Generics Manufacturer

Head of Regulatory Affairs
“Alchemy’s expertise in MA Holding ensured our product’s smooth market entry with full compliance.”

Specialty Pharma

Director